Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment 3d-crt or imrt
Phase phase 3
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date March 2002
End date April 2014
Trial size 1532 participants
Trial identifier NCT00033631, CDR0000069306, RTOG-0126

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients undergo standard-dose three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for 7.8 weeks (39 treatment days).
3d-crt or imrt
Given 5 days a week for 7.8 or 8.8 weeks
(Experimental)
Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).
3d-crt or imrt
Given 5 days a week for 7.8 or 8.8 weeks

Primary Outcomes

Measure
Overall survival
time frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.

Secondary Outcomes

Measure
Prostate-specific antigen failure by American Society for Therapeutic Radiology and Oncology (ASTRO) definition
time frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurs after patients have been potentially followed for 5 years.
Disease specific survival
time frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.
Local progression
time frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Distant metastases
time frame: From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Grade 2 or greater genitourinary or gastrointestinal toxicity
time frame: From the start of treatment to last follow-up.
Erectile Function by International Index of Erectile Function (IIEF)
time frame: From randomization to 5 years.
Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)
time frame: From randomization to 5 years.
Quality adjusted survival by SQLI
time frame: From randomization to 5 years.

Eligibility Criteria

Male participants up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Clinical stage T1b-T2b - Meets one of the following criteria: - Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL - Gleason score 7 AND PSA < 15 ng/mL - No regional lymph node involvement - No distant metastases PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer - No other major medical or psychiatric illness that would preclude study participation - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior cytotoxic chemotherapy - No concurrent cytotoxic chemotherapy Endocrine therapy: - At least 3 months since prior finasteride - No other prior hormonal therapy, including: - Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) - Antiandrogens (e.g., flutamide or bicalutamide) - Estrogens (e.g., diethylstilbestrol) - No concurrent (neoadjuvant or adjuvant) hormonal therapy Radiotherapy: - No prior pelvic irradiation or prostatic brachytherapy Surgery: - No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer - No prior surgical castration (bilateral orchiectomy) Other: - At least 3 months since prior finasteride or PC SPES

Additional Information

Official title A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Description OBJECTIVES: - Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy. - Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. - Compare the probability of tumor control and normal tissue complications in patients treated with these regimens. - Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens. - Compare the quality of life, including sexual function, of patients treated with these regimens. - Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days). - Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days). Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.