Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer (NCT01368588) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
United States2,590 participantsStarted 2011-07
Plain-language summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with 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:
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
* Gleason score 7-10 + T1c-T2b (palpation) + PSA \< 50 ng/ml (includes intermediate and high risk patients);
* Gleason score 6 + T2c-T4 (palpation) + PSA \< 50 ng/ml
-ORGleason score 6 + ≥ 50% (positive) biopsies + PSA \< 50 ng/ml;
* Gleason score 6 + T1c-T2b (palpation) + PSA \> 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
* History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
* Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration.
* Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
\*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
* Equivocal bone scan findings are allowed if …
What they're measuring
1
Percentage of Participants Alive (Overall Survival)
Timeframe: From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.