Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00091390
First received: September 7, 2004
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: brachytherapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment [ Time Frame: From registration until 9 months from the start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute severe GU and GI toxicity as measured by CTCAE v3.0 within 9 months of starting treatment [ Time Frame: From registration until 9 months from the start of treatment ] [ Designated as safety issue: Yes ]
  • Biochemical failure [ Time Frame: From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
  • Clinical progression including local/regional and distant relapse [ Time Frame: From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: July 2004
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBRT and HDR brachytherapy boost
External beam radiation therapy (EBRT), 45 Gy and High dose rate (HDR) brachytherapy boost, 19 Gy in 2 fractions
Radiation: brachytherapy Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.

Secondary

  • Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
  • Determine freedom from biochemical failure in patients treated with this regimen.
  • Determine overall survival of patients treated with this regimen.
  • Determine disease-specific survival of patients treated with this regimen.
  • Determine clinical relapse (local and/or distant) in patients treated with this regimen.
  • Develop a quality assurance process for high-dose rate prostate brachytherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).

Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over approximately 5-30 minutes either before or after external beam radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Clinical stage T1c-T3b
    • No clinically or pathologically involved lymph nodes (N0 by pelvic CT scan or MRI)
    • No distant metastases (M0 by negative bone scan)
  • Meets one of the following combination criteria:

    • Clinical stage T1c-T2c, Gleason score 2-6, and prostate-specific antigen (PSA) > 10 but ≤ 20 ng/mL
    • Clinical stage T3a-T3b, Gleason score 2-6, and PSA ≤ 20 ng/mL
    • Clinical stage T1c-T3b, Gleason score 7-10, and PSA ≤ 20 ng/mL

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Fertile patients must use effective contraception
  • No hip prosthesis
  • No major medical or psychiatric illness that would preclude study participation
  • No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in situ of the oral cavity or bladder) or any other malignancy with a disease-free status ≥ 3 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • Prior induction hormonal therapy allowed provided therapy was initiated within 90 days before study enrollment

Radiotherapy

  • No prior pelvic or prostate radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • No prior radical surgery for prostate cancer
  • No prior transurethral resection of the prostate
  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 ClinicalTrials.gov identifier: NCT00091390

Locations
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States, 33486
United States, Illinois
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Wisconsin
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: I-Chow J. Hsu, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00091390     History of Changes
Other Study ID Numbers: RTOG-0321, CDR0000382120
Study First Received: September 7, 2004
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014