Clinical Trial Details

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Study ID RTOG-0924
Investigator
Mack Roach, MD,   University of California, San Francisco
Title Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Conditions Prostate Cancer
Interventions Radiation: radiation therapy
Radiation: selective external radiation therapy
Phase Phase 3
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients) - Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 50 ng/mL - Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL
  • History and/or 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 and/or 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 - Patients status post a negative lymph node dissection are not eligible
  • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration - Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration
  • Study entry PSA should not be obtained during the following time frames: - Ten-day period following prostate biopsy - Following initiation of hormonal therapy - Within 30 days after discontinuation of finasteride - Within 90 days after discontinuation of dutasteride PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis - E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed - No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
  • No severe, active co-morbidity, defined as any of the following: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition - Protocol-specific requirements may also exclude immuno-compromised patients - HIV testing is not required for entry into this protocol
  • No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  • No prior allergic reaction to the hormones involved in this protocol PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration (orchiectomy)
  • No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
  • No finasteride within 30 days prior to registration
  • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer - Prior chemotherapy for a different cancer is allowable
  • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  • Study Location
    Providence Cancer Center
    Anchorage, Alaska, 99508
    Contact Clinical Trials Office - Providence Cancer Center
    907-261-3109
    Information objtained from ClinicalTrials.gov, on 4/18/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01368588


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