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Clinical trial

Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer

Read time: 3 mins
Last updated:1st Feb 1998
Source: Clinical Trials
Identifier: NCT00002874

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

Primary Outcome Measures:

  • Overall Survival [ Time Frame: From date of randomization to date of death. ]

Secondary Outcome Measures:

  • Disease Specific Survival [ Time Frame: From date of randomization to date of death certified as prostatic cancer or death with know rising PSA or death with known progressive metastatic disease or death due to complication of treatment ]
  • Time to Distant Failure [ Time Frame: From the date of randomization to the date of first documented metastatic disease. ]
  • Non-disease Specific Survival [ Time Frame: From the date of randomization to the date of any death that is not disease specific. ]
  • Freedom from Progression [ Time Frame: From the date of randomization to the date of first occurrence of PSA failure, clinical failure or death from any cause. ]
Category Value
Date last updated at source 2017-05-18
Study type(s) Interventional
Expected enrolment 840
Study start date 1998-02-01
Estimated primary completion date 2015-08-01

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