Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI) Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002874

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 Procedure: low-LET cobalt-60 gamma ray therapy Procedure: low-LET photon therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide Cobalt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 1998

Detailed Description:

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, and 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.
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

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002874

Show 240 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Southwest Oncology Group

Investigators

Study Chair:	William U. Shipley, MD, FACR	Massachusetts General Hospital
Study Chair:	H. B. Grossman, MD	M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000065158, RTOG-9601, RTOG-R9601
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002874
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage III prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Cobalt
Bicalutamide
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009