Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Study Start Date: | February 1998 |
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.
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.
PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within approximately 3 years.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Karnofsky 80-100%
Life expectancy:
- More than 10 years
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
- 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
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
Contacts and Locations
Show 240 Study Locations| Study Chair: | William U. Shipley, MD, FACR | Massachusetts General Hospital |
| Study Chair: | H. B. Grossman, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002874 History of Changes |
| Other Study ID Numbers: | CDR0000065158, RTOG-9601, RTOG-R9601 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Bicalutamide |
Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013