Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002889
• Other study ID #: CALGB-9682
• Secondary ID: U10CA031946CLB-9
• Status: Completed
• Phase: Phase 2
• Start date: May 1997
• Est. completion date: June 2009

Study information

• Verified date: August 2023
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2009
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• flutamide

• goserelin

• leuprolide acetate

Radiation:
• low-LET photon therapy

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Joint Center for Radiation Therapy	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	St. Joseph's Hospital and Medical Center	Paterson	New Jersey
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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]

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-ri — View 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 h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		2 years post tx