Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

NCT ID: NCT00002889

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-05-31
• Study Completion Date: 2009-06-30

Brief Summary

RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.

PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.

Detailed Description

OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.

OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.

PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

flutamide

Intervention Type: DRUG

goserelin

Intervention Type: DRUG

leuprolide acetate

Intervention Type: DRUG

low-LET photon therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate AJCC stage T1b-T4b, N0 or Nx, M0 Transrectal, transperineal, or transurethral biopsy required

PATIENT CHARACTERISTICS: Age: 30 and over Performance status: CALGB 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: The following may increase the risk of protocol treatment: Serious intercurrent medical illness that might compromise patient safety Active acute infection requiring antibiotics Suppression therapy for chronic urinary tract infection allowed Uncontrolled or severe cardiovascular disease Psychiatric conditions that prevent compliance or informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for carcinoma of the prostate Endocrine therapy: No prior androgen deprivation therapy (medical or surgical) Radiotherapy: No prior radiation therapy for carcinoma of the prostate Surgery: No prior surgical androgen deprivation therapy

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony V. D'Amico, MD, PhD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Joint Center for Radiation Therapy

Boston, Massachusetts, United States

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

D'Amico AV, Halabi S, Tempany C, Titelbaum D, Philips GK, Loffredo M, McMahon E, Sanford B, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B. Tumor volume changes on 1.5 tesla endorectal MRI during neoadjuvant androgen suppression therapy for higher-risk prostate cancer and recurrence in men treated using radiation therapy results of the phase II CALGB 9682 study. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):9-15. doi: 10.1016/j.ijrobp.2007.09.033. Epub 2007 Nov 26.

Reference Type: RESULT

PMID: 18037582 (View on PubMed)

D'Amico AV, Halabi S, Vollmer R, Loffredo M, McMahon E, Sanford B, Archer L, Vogelzang NJ, Small EJ, Kantoff PW; Cancer and Leukemia Group B. p53 protein expression status and recurrence in men treated with radiation and androgen suppression therapy for higher-risk prostate cancer: a prospective phase II Cancer and Leukemia Group B Study (CALGB 9682). Urology. 2008 May;71(5):933-7. doi: 10.1016/j.urology.2007.11.005. Epub 2008 Feb 21.

Reference Type: RESULT

PMID: 18291508 (View on PubMed)

D'Amico AV, Halabi S, Tempany C, et al.: Changes on endorectal MRI during neoadjuvant hormonal therapy for prostate cancer and biochemical outcome in men managed using radiation therapy: a prospective phase II Cancer and Leukemia Group B study. [Abstract] J Clin Oncol 25 (Suppl 18): A-5072, 252s, 2007.

Reference Type: RESULT

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLB-9682

Identifier Type: -

Identifier Source: secondary_id

CDR0000065212

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-9682

Identifier Type: -

Identifier Source: org_study_id