Radiation Therapy in Treating Patients With Stage II Prostate Cancer (NCT00033631) | Clinical Trial Compass
CompletedPhase 3
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
United States1,534 participantsStarted 2002-03
Plain-language summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Clinical stage T1b-T2b
* Meets one of the following criteria:
* Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but \< 20 ng/mL
* Gleason score 7 AND PSA \< 15 ng/mL
* No regional lymph node involvement
* No distant metastases
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
* No other major medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior cytotoxic chemotherapy
* No concurrent cytotoxic chemotherapy
Endocrine therapy:
* At least 3 months since prior finasteride
* No other prior hormonal therapy, including:
* Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
* Antiandrogens (e.g., flutamide or bicalutamide)
* Estrogens (e.g., diethylstilbestrol)
* No concurrent (neoadjuvant or adjuvant) hormonal therapy
Radiotherapy:
* No prior pelvic irradiation or brachytherapy
Surgery:
* No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
* No prior surgical castration (bilateral orchiectomy)
Other:
* At least 3 months since prior finaster…
What they're measuring
1
Overall Survival
Timeframe: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.