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Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
flutamide
goserelin
leuprolide acetate
low-LET photon therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Cancer Center and Cancer Research Institute
  • Walter Reed Army Medical Center
  • University of Chicago Cancer Research Center
  • Dana-Farber Cancer Institute
  • Joint Center for Radiation Therapy
  • St. Joseph's Hospital and Medical Center
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 16, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002889
Brief Title
Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
Official Title
PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Drug
Intervention Name(s)
goserelin
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Intervention Type
Radiation
Intervention Name(s)
low-LET photon therapy
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
2 years post tx

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony V. D'Amico, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Joint Center for Radiation Therapy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18037582
Citation
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.
Results Reference
result
PubMed Identifier
18291508
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

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