Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments 3-dimensional conformal radiation therapy (3d-crt), hypofractionated radiation therapy, intensity-modulated radiation therapy (imrt)
Phase phase 3
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2006
End date July 2015
Trial size 1115 participants
Trial identifier NCT00331773, CDR0000481119, NCI-2009-00721, RTOG-0415

Summary

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may kill more tumor cells and have fewer side effects. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).
3-dimensional conformal radiation therapy (3d-crt)
41 or 28 treatments
intensity-modulated radiation therapy (imrt)
41 or 28 treatments
(Experimental)
Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).
3-dimensional conformal radiation therapy (3d-crt)
41 or 28 treatments
hypofractionated radiation therapy
Once daily 5 days a week for 5.6 weeks
intensity-modulated radiation therapy (imrt)
41 or 28 treatments

Primary Outcomes

Measure
Disease-free survival
time frame: From randomization to date of disease-free failure event, defined as local progression, distant progression, or biochemical failure, or last follow-up.

Secondary Outcomes

Measure
Local Progression
time frame: From randomization to date of local progression or last follow-up. Analysis occurs at the time of the primary endpoint analysis.
Disease-specific survival
time frame: From randomization to date of death due to prostate cancer or last follow-up. Analysis occurs at the time of the primary endpoint analysis.
Freedom from biochemical recurrence (FFBR)
time frame: From randomization to date of biochemical failure or last follow-up. Analysis occurs at the time of the primary endpoint analysis.
Overall survival
time frame: From randomization to date of death or last follow-up. Analysis occurs at the time of the primary endpoint analysis.
Incidence of GU and GI acute and late toxicity
time frame: Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occurs at the time of the primary endpoint analysis.
Statistical modeling of genomic biomarkers
time frame: Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis.
Comparison of disease-specific HRQOL change in EPIC; the Utilization of Sexual Medications/Devices supplements the EPIC
time frame: From baseline to 5 years from the start of treatment.
Assessment of anxiety and depression change using the HSCL-25
time frame: From baseline to 5 years from the start of treatment.
Evaluation and comparison of the cost-utility of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis
time frame: From baseline to 5 years from the start of treatment.
Collection of paraffin-embedded tissue block, serum, plasma, and buffy coat cells for future translational research analyses
time frame: From baseline to 5 years from the start of treatment.

Eligibility Criteria

Male participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate within the past 6 months - Clinical stage T1-2c - Combined Gleason score 2-6 - Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months - No PSA measurement for ≥ 10 days after prostate biopsy - No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation of dutasteride) - No regional lymph node involvement - No distant metastases PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months - No transmural myocardial infarction within the past 6 months - No acute bacterial or fungal infection requiring IV antibiotics - No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment - No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - No known AIDS - No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity) - No other severe, active comorbidity PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radical prostatectomy or cryosurgery for prostate cancer - No prior hormonal therapy, including any of the following: - Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) - Antiandrogens (e.g., flutamide or bicalutamide) - Estrogens (e.g., diethylstilbestrol [DES]) - Surgical castration (bilateral orchiectomy) - No prior pelvic radiotherapy or prostate brachytherapy - No prior or concurrent cytotoxic chemotherapy for prostate cancer - At least 30 days since prior finasteride - At least 90 days since prior dutasteride - No concurrent neoadjuvant or adjuvant hormonal therapy - Concurrent warfarin or other blood-thinning agents allowed

Additional Information

Official title A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
Description OBJECTIVES: Primary - Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT). Secondary - Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens. - Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens. - Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens. - Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients . - Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens. - Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs 4-9 ng/mL), and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments). - Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments). Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.