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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Southwest Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group Identifier:
First received: November 1, 1999
Last updated: September 28, 2016
Last verified: September 2016

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization to date of death. ]

Secondary Outcome Measures:
  • Disease Specific Survival [ Time Frame: From date of randomization to date of death certified as prostatic cancer or death with know rising PSA or death with known progressive metastatic disease or death due to complication of treatment ]
  • Time to Distant Failure [ Time Frame: From the date of randomization to the date of first documented metastatic disease. ]
  • Non-disease Specific Survival [ Time Frame: From the date of randomization to the date of any death that is not disease specific. ]
  • Freedom from Progression [ Time Frame: From the date of randomization to the date of first occurrence of PSA failure, clinical failure or death from any cause. ]

Enrollment: 840
Study Start Date: February 1998
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation therapy plus Casodex (bicalutamide)
Radiation therapy plus Casodex (bicalutamide) 150 mg
Drug: bicalutamide
Other Name: Casodex
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy
Placebo Comparator: Radiation therapy plus Placebo
Radiation therapy plus placebo daily
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy

Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • More than 10 years


  • White blood cell count (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


  • Bilirubin normal
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 2.5 times normal


  • Creatinine no greater than 2 times normal


  • No other malignancy within the past 5 years except basal or squamous cell skin cancer or adequately treated invasive cancers


Biologic therapy:

  • No prior biologic therapy for prostate cancer


  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • No prior adjuvant hormonal therapy
  • Prior neoadjuvant hormonal therapy allowed


  • No prior radiotherapy for prostate cancer


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002874

  Show 240 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
NRG Oncology
Study Chair: William U. Shipley, MD, FACR Massachusetts General Hospital
Study Chair: H. B. Grossman, MD M.D. Anderson Cancer Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00002874     History of Changes
Other Study ID Numbers: RTOG-9601
Study First Received: November 1, 1999
Last Updated: September 28, 2016

Keywords provided by Radiation Therapy Oncology Group:
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
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents processed this record on April 28, 2017