Full Text View
Tabular View
No Study Results Posted
Related Studies
Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
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
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
 Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy
Drug Information available for: Bicalutamide Cobalt
U.S. FDA Resources

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, 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
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

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

No publications provided

Study ID Numbers: CDR0000065158, RTOG-9601, RTOG-R9601
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002874     History of Changes
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:
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
 Recurrence
Carcinoma
Androgen Antagonists
Cobalt
Bicalutamide
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
 Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services