Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate CancerApr 2013
Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study. Group 1: Hemi-ablation of the prostate at the side of the positive biopsies (hemi-ablation) Group 2: Total ablation of the prostate (total ablation) Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.
Atorvastatin and Prostate Cancer (ESTO1)Mar 2013
This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)Feb 2013
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)
A Phase I Trial of AZD3965 in Patients With Advanced CancerFeb 2013
The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed and what happens to AZD3965 inside the body.
Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in HumansFeb 2013
Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation. The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.
Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate CancerFeb 2013
The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy (NoHarm)Feb 2013
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate CancerFeb 2013
To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression- free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)Feb 2013
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery (CARLHA)Jan 2013
As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.
Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)Jan 2013
The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.
A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)Jan 2013
In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Effect of chemotherapy on endothelial function in patients with testicular cancerJan 2013
The aim is to study possible adverse effects of chemotherapy on endothelial function1
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)Dec 2012
To determine whether abiraterone acetate in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis TumoursNov 2012
High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.
A phase III single arm study to evaluate the efficacy, safety and local tolerability of a subcutaneous 3‑month formulation of triptorelin pamoate (11.25 mg) in patients with locally advanced or metastatic prostate cancer.Oct 2012
To confirm the efficacy of triptorelin pamoate (11.25 mg)prolonged release (PR) formulation by inducing castration (defined as serum testosterone level of <50 ng/dL or <1.735 nmol/L) at Day 29 and maintaining castration at Day 183 (after receiving two subcutaneous (s.c.) administrations of triptorelin pamoate, 3 months apart).
A Randomized, Double-blind, Comparative Study of ZYTIGA (Abiraterone Acetate) Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)Oct 2012
To determine whether ZYTIGA in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100Aug 2012
The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment. The ReCab trialAug 2012
To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.
Phase Ib dose finding study of abiraterone acetate plus BEZ235 or BKM120 in patients with castration-resistant prostate cancerJul 2012
Dose escalation part: Define maximum tolerated dose (MTD) and /or recommended dose for expansion (RDE) of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1. Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment Prostate specific antigen (PSA) progression according to prostate cancer working group 2 criteria (PCWG2) by assessing PSA decline ? 30% at Week 12 or later.
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to HistopathologyJun 2012
. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone MetastasisJun 2012
To assess acute and long-term safety and overall survival in patients with castration-resistant (hormone-refractory) prostate cancer.
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone MetastasisJun 2012
Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis To assess acute and long-term safety of radium-223 chloride
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell TumorsMay 2012
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to AbirateroneMay 2012
Part A: • To assess the safety and tolerability (incidence and severity of adverse events [AEs]) of the combination of AT13387 and abiraterone acetate and to select the most promising treatment regimen for the combination in subjects with castration-resistant prostate cancer (CRPC) who are no longer responding to treatment with abiraterone acetate alone, based on the overall assessment of safety and antitumor activity. Part B: • To assess and compare the antitumor activity (response rate per the Prostate Cancer Working Group 2 [PCWG2] recommendations) between single-agent AT13387 and the combination of AT13387 plus abiraterone acetate in subjects who are no longer responding to treatment with abiraterone acetate alone.
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate CancerMay 2012
To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm
A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancerMay 2012
The objective of this study is to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone.
Effects of short-term atorvastatin treatment on prostate cancer - a pre-surgical pilot trialMay 2012
Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment.
A Phase 3bMulticenter, Open-label Abiraterone Acetate Long-term Safety StudyApr 2012
To collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate CancerApr 2012
To evaluate the effects of orteronel, when administered with prednisone, on the QT/QTc interval in patients with metastatic castration-resistant prostate cancer (mCRPC)
An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate CancerMar 2012
The purpose of the study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Sipuleucel-T (Provenge®) is approved for use in the US by the Food and Drug Administration for the treatment of metastatic castrate resistant prostate cancer. The study sponsor, Dendreon Corporation is applying for Manufacturing Authorization in Europe. The intent of this study is to demonstrate that sipuleucel-T manufactured in Europe results in the same cellular activation as seen in sipuleucel-T produced in the US.
TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.Mar 2012
The primary objective of this study is to evaluate the activity of olaparib in patients with advanced prostate cancer who have progressed following one or two chemotherapy regimens including docetaxel.
Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)Feb 2012
To determine which anthropometric parameters Lean body mass, total body mass or body surface area correlates best to docetaxel exposure (AUC) .
An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice every 84 daysFeb 2012
Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).
Taste, Smell and Chemotherapy (TASTY)Jan 2012
Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.
A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients.Jan 2012
To determine the estradiol suppression between the three treatment arms after three months.
A Phase I/II Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC) whose Disease has Progressed after Docetaxel ChemotherapyJan 2012
To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in patients with metastatic CRPC To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of PSA response rate
Role of PET/CT with 18F-choline in biochemical relapse in prostate cancer patients treated with radical intent. Pet Col study.Dec 2011
To assess the sensitivity of Pet Ct
A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate Cancer ConWeCabDec 2011
To determine if a weekly regime improves tolerability of cabazitaxel compared to the standard 3 week regimen
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate CancerNov 2011
To ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trialNov 2011
To assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of PSA in patients treated with BT for low-intermediate risk localized prostate carcinoma
Everolimus in Refractory Testicular Germ Cell CancerOct 2011
Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated with Docetaxel.Oct 2011
Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.
A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate CancerAug 2011
The primary objective of the study is to determine the safety and tolerability of orally-administered VT-464 in chemotherapy-naïve patients with castration-refractory prostate cancer (CRPC).
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation TherapyAug 2011
To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients
A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESCAug 2011
To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea
An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.Aug 2011
To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.
Testosterone Replacement in Young Male cancer SurvivorsAug 2011
The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone.
A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON)Jun 2011
We propose a study to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. The study aims to determine the efficacy of carbogen gas breathing and nicotinamide tablets, given during a course of intensity-modulated radiotherapy to the prostate gland in previously untreated patients with prostate cancer.
MR Image Guided Therapy in Prostate CancerJun 2011
To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational StudyJun 2011
The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital.
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with ChemotherapyMay 2011
To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy
SAPROCAN: Saracatinib (AZD0530) and docetaxel in metastatic, castrate-refractory prostate cancer: a phase I/randomised phase II study by the UK NCRI Prostate Clinical Studies GroupMar 2011
For the first part of the study (phase I), the primary objective is to find a safe and tolerable dose for saracatinib (AZD0530) given in combination with standard chemotherapy treatment (docetaxel and prednisolone) for patients with metastic castrate-refractory prostate cancer. For the second part of the study (phase II), the primary objective is to investigate whether we can improve the benefits of chemotherapy cancer treatment for patients with metastic castrate-refractory prostate cancer by adding a new drug, saracatinib (AZD0530).
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)Mar 2011
To assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
A phase 2, open-label, single-arm, efficacy and safety study of MDV3100 in patients with hormone-naïve prostate cancerFeb 2011
To evaluate the effect of MDV3100 on prostate-specific antigen (PSA)
Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate CancerFeb 2011
To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer (RADIT)Nov 2010
The purpose of this study is to determine whether the drug everolimus is effective in the treatment of patients with relapsed cancer of the testis.
Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer.Nov 2010
To test whether adjuvant tratment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation.
The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical TrialOct 2010
The primary objective of the research project is to determine the effect of twelve weeks’ treatment with an aromatase inhibitor (Femara®, 2.5mg weekly) on the change in the serum concentration of the pro-inflammatory cytokine, C Reactive Protein, as measured by the Roche® Cobas immuno-turbidimetric test and compare it to that of twelve weeks’ treatment with a depot intramuscular formulation of testosterone undecanoate (Nebido®, 1g every 6 weeks) and to that of six weeks of no treatment.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based TherapyOct 2010
To determine if orteronel plus prednisone improves overall survival (OS)
Multicentre, single-arm, open label clinical trial intended to provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen and to document safety of cabazitaxel in these patientsOct 2010
To allow patients similar to those evaluated in the TROPIC trial, and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in patients who have progressed during or after docetaxel, and to document the overall safety of cabazitaxel in these patients.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate CancerSep 2010
To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab
A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active SurveillanceAug 2010
To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in risk of treatment failure associated with observed histological progression of disease in men with low risk prostate cancer who undergo TOOKAD® Soluble VTP compared to men on active surveillance (co-primary objective B).
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer. Revised Protocol Number 01 incorporating Administrative Letters 01 and 02 and Amendment 05 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 3.0 dated 11-Jan-10) + Immune Monitoring Amendment 04 (version 1.0 dated 18-Mar-11)-Site SpecificAug 2010
To compare overall survival of subjects with chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC) who have been randomized to ipilimumab vs placebo.
PET Acetate for Castrate-Resistant Prostate Cancer on ChemotherapyJun 2010
One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer.
Multicenter phase 2 trial of arq 197 for subjects with relapsed or refractory germ cell tumorsMar 2010
The primary objective is to determine the objective response rate (ORR) after 4 cycles of therapy with ARQ 197 in subjects with GCT.
Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer populationMar 2010
In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily for six months result in a change in volume of prostate cancer, as assessed by MRI (T2 weighted)?
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients (PROTECT-Z)Nov 2009
to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree RelativesNov 2009
This clinical trial is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer and their first-degree relatives.
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular CancerNov 2009
Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.
Prostate Cancer Symptom Management for Low Literacy MenSep 2009
This study will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care.
A single group trial evaluating one cycle of adjuvant BEP chemotherapy in high risk, stage 1 non-seminomatous germ cell tumours of the testis (NSGCTT)Sep 2009
To show that one cycle of adjuvant BEP chemotherapy results in a 2 year recurrence rate of less than 5% in patients with high-risk stage 1 NSGCTT
Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate CancerAug 2009
The purpose of this study is: To evaluate the utility of F-18-FCH-PET/CT and MR imaging with 3-D MR spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current standard work-up using TRUS-guided biopsy. All imaging findings will be correlated with "gold standard" step slice histological examination. The hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach. To evaluate FCH-PET for the restaging of prostate cancer after biochemical relapse in a large patient cohort. This will run in parallel to the work-up of primary prostate cancer, as the FCH radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18-FCH-PET/CT for these patients and this indication is currently not reimbursed by Swiss obligatory health insurance providers.
A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistant Prostate Cancer That Have Received Prior Treatment with Docetaxel. Revised Protocol 05 incorporating Protocol Amendments 04, 09, 11,12 and 14 + Biomarker Amendment 06 (version 1.0 dated 16-Nov-09) - Site Specific + Serum Biomarker Amendment 13 (Version 1.0 dated 18-Mar-11) - Site SpecificJul 2009
To compare overall survival of subjects with castration resistant prostate cancer (CRPC), that have progressed during or following docetaxel treatment, when randomized to treatment with bone-directed radiotherapy followed by ipilimumab vs bone-directed radiotherapy followed by placebo.
High-dose Chemotherapy for Poor-prognosis Relapsed Germ-Cell TumorsJun 2009
The goal of this clinical research study is to learn if bevacizumab, when given in combination with 2 cycles of high-dose chemotherapy, can help to control germ-cell tumors.
Vascular-targeted photodynamic therapy using WST11 in patients with localised prostate cancerMay 2009
To determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer with both normal (<60cc) and high-volume prostates (≥60cc).
Non-invasive detection of prostate cancer using functional MRI in patients with histopathologically confirmed prostate cancer before prostatectomyMay 2009
The main object of the trial is to assess the diagnostic value of functional MRI (T2+DCE MRI) for the detection of prostate cancer (on the basis of 16 prostate segments) and to show superiority in the accuracy to detect prostate cancer compared to conventional T2 MRI (SOR: histopathology)
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic CancerMay 2009
This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate CancerFeb 2009
The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses.
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local TherapyOct 2008
The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancerJul 2008
Determination of the potentiality of SonoVue to guide prostate biopsy increasing the detection rate of malignant lesions of 6% points in absolute terms compared to the detection rate of the conventional systematic biopsy on patients candidates to a bioptic procedure. The study population comprises both candidates to a first bioptic exam and candidates to a second bioptic procedure having had a previous negative result independently from the present study.
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer PatientsJun 2008
This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose DistributionMar 2008
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases.Mar 2008
To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).
Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial NeoplasiaJan 2008
The clinical study is a Phase II, randomized, double-blinded, placebo-controlled trial in men 30-80 years of age with biopsy proven HGPIN or atypical small acinar proliferation (ASAP) and no evidence of prostate cancer, prostatitis or urinary tract infection. A total of 272 men will be randomized to the study, with the goal of completing 240 evaluable participants. Participants who consent to the study and meet initial eligibility criteria will be undergo a one-week run-in period during which they will be asked to self-administer the supplement daily as well as complete study logs and two-day diet recall forms. Participants must meet all inclusion criteria and remain compliant during the run-in period to be randomized to a treatment arm. Participant will complete a quality of life (QOL) survey and have blood collected for baseline tests. Participants will be equally randomized (n=136 per arm) to blinded treatment with either Polyphenon E 200 mg epigallocatechin gallate (EGCG) twice a day (bid) or matching placebo. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and other and lower urinary tract symptom (LUTS) and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood and urine will be collected, and repeat digital rectal exam (DRE) and prostatic specific antigen (PSA) will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat biopsy will be performed. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. The primary endpoint of the study is a comparison of the incidence of prostate cancer between participants in the treatment vs. placebo arm; in addition, the prevalence of HGPIN or ASAP in pre-treatment and post-treatment biopsies in participants treated with Polyphenon E vs. placebo will be compared. If participants develop prostate cancer during the course of the study, the extent and grade of cancer will be assessed and compared between treatment groups.
Coping in African American Prostate Cancer Survivors (CAAPS)Dec 2007
This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer.
Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black MenDec 2007
This study is being done to see if a standard tool used to check anxiety in white men works well for Black men.
Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21Dec 2007
The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate CancerDec 2007
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate CancerMar 2007
To determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with prostate cancer.
An Open-Label, Multi-Centre, Extension Study, evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens, 240 mg (40 mg/mL), 240 mg (60 mg/mL), in Patients with Prostate Cancer.Jan 2006
To evaluate the safety and tolerability of different dosing regimens