Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments brachytherapy, radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2004
End date January 2008
Trial size 129 participants
Trial identifier NCT00091390, CDR0000382120, RTOG-0321

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
External beam radiation therapy (EBRT), 45 Gy and High dose rate (HDR) brachytherapy boost, 19 Gy in 2 fractions
brachytherapy
radiation therapy

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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.
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.
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.
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.

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.