Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.
Primary Outcome Measures:
- Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: not yet evaluable ]
- Metastases-free survival [ Time Frame: not yet evaluable ]
- Immediate and delayed toxicities [ Time Frame: not yet evaluable ]
- Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ]
- Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ]
- Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ]
| Category | Value |
|---|---|
| Date last updated at source | 2015-02-02 |
| Study type(s) | Interventional |
| Expected enrolment | 743 |
| Study start date | 2006-10-01 |
| Estimated primary completion date | 2015-01-01 |