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Phase III Randomized Study of Radiotherapy With Or Without Bicalutamide in Patients With PSA Elevation Following Radical Prostatectomy for Carcinoma of the Prostate
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Treatment | Completed | Any age | RTOG-9601 RTOG 96-01, RTOG-R9601, NCT00002874, RTOG-96-01 |
Special Category:
CTSU trial Objectives - Compare overall survival following radiotherapy with or without bicalutamide in patients with an elevated prostate-specific antigen (PSA) and no evidence of metastatic disease following radical prostatectomy for pathologic T3 N0 prostate cancer.
- Compare each regimen with respect to time to second PSA-based progression, time to distant failure, disease-specific survival, and non-disease-specific survival in this patient population.
- Compare each regimen with respect to time to third PSA failure (or PSA progression on hormone therapy for second PSA failure) as a potential predictor for impending cancer death in these patients.
- Compare each regimen with respect to 5-year and 10-year freedom from progression rates.
- Compare each regimen with respect to unintended adverse effects on treatment.
- Allow for subsequent analysis of emerging molecular pathologic predictors of outcome with the prospective collection of paraffin blocks from the radical prostatectomy specimen.
Entry Criteria Disease Characteristics:
- Carcinoma of the prostate with pathologic stage T3 N0 or pT2 pN0 with
positive
inked resection margin at least 12 weeks prior to study entry
- Radical prostatectomy (retropubic or perineal) and pelvic lymphadenectomy
(open or laparoscopic) required at least 16 weeks prior to entry
- No persistent urinary extravasation after surgery
- Suitable for radiotherapy and hormonal therapy as determined by the
radiation
oncologist and urologist
- No metastasis by post-prostatectomy radioisotope bone scan within 16
weeks prior to entry
- Pathologic stage T2 without positive margins and pathologic N0 with
prostatic
fossa/anastamosis biopsy at the time of rising PSA
documenting recurrent
cancer allowed
- PSA 0.2-4.0 ng/mL at study entry
- No distant metastases
Prior/Concurrent Therapy:
Biologic therapy: - No prior biologic therapy for prostate cancer
Chemotherapy: - No prior chemotherapy for prostate cancer
Endocrine therapy: - No prior adjuvant hormonal therapy
- Prior neoadjuvant hormonal therapy allowed
Radiotherapy: - No prior radiotherapy for prostate cancer
Surgery: - See Disease Characteristics
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
- Hematocrit at least 36%
- Hemoglobin at least 10 g/dL
Hepatic: - Bilirubin normal
- AST or ALT no greater than 2.5 times normal
Renal: - Creatinine no greater than 2 times normal
Other: - No other malignancy within the past 5 years except basal
or squamous cell skin cancer or adequately treated invasive
cancers
Expected Enrollment A total of 810 patients will be accrued for this study within approximately 3
years. Outline This is a randomized, double-blind, multicenter study. Patients are
stratified by neoadjuvant hormone therapy, surgical (inked) margin status, PSA
nadir after surgery, PSA level at entry, and participating center. All patients undergo radiotherapy to the original prostate volume, tumor
resection bed, and proximal membranous urethra over 7.2 weeks. Beginning
immediately upon or just prior to the initiation of radiotherapy, patients are
randomized to receive either bicalutamide or placebo daily for 2 years. Recommended treatment for patients with increasing PSA and bone
metastases consists of maximal androgen blockage with a combination of
orchiectomy or LHRH analogues plus bicalutamide or flutamide. Patients are followed every 3 months for 2 years, every 6 months for 3
years, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group | | | William Shipley, MD, FACR, Protocol chair | | | |
Southwest Oncology Group | | | H. Grossman, MD, Protocol chair | | Ph: 713-792-3250; 800-392-1611 |
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Registry Information | | Official Title | | A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE | | Trial Start Date | | 1998-02-15 | | Registered in ClinicalTrials.gov | | NCT00002874 | | Date Submitted to PDQ | | 1996-01-10 | | Information Last Verified | | 2003-03-27 | | NCI Grant/Contract Number | | CA21661 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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