Phase 3
Completed N=1,115
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Source: ClinicalTrials.gov NCT00331773 ↗Enrolled (actual)
1,115
Serious AEs
5.6%
Results posted
Apr 2017
Primary outcomePrimary: Five-year Disease-free Survival (DFS) Rate — 85.3; 86.3 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
630citations · ~63 / year
Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer.
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 be less costly with fewer side effects and just as 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.
Linked Publications (5)
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Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer.
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Long-Term Analysis of NRG Oncology RTOG 0415: A Randomized Phase III Noninferiority Study Comparing Two Fractionation Schedules in Patients With Low-Risk Prostate Cancer.
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Neighborhood Deprivation and Rurality Associated With Patient-Reported Outcomes and Survival in Men With Prostate Cancer in NRG Oncology RTOG 0415.
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Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer.
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Conditional Risks of Biochemical Failure and Prostate Cancer-Specific Death in Patients Undergoing External Beam Radiotherapy: A Secondary Analysis of 2 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five-year Disease-free Survival (DFS) Rate |
85.3; 86.3 | <0.001 sig |
| SECONDARY Five-year Local Progression Rate |
1.2; 0.4 | — |
| SECONDARY Five-year Disease-specific Survival Rate |
0.2; 0.2 | — |
| SECONDARY Five-year PSA Failure Rate |
8.1; 6.3 | < 0.001 sig |
| SECONDARY Five-year Overall Survival Rate |
93.2; 92.5 | 0.008 sig |
| SECONDARY Frequency of Patients With GU and GI Acute and Late Toxicity |
55; 58; 3; 4; 145; 147 | 0.85 |
| SECONDARY Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC |
-4; -3.7; 0; -1.5; -8.1; -7.8 | 0.72 |
| SECONDARY The Utilization of Sexual Medications/Devices Questionaire |
2.0; 0.0; 24.5; 23.0; 2.5; 0.6 | — |
| SECONDARY Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 |
31.2; 31.8; 31.2; 32.2; 31.1; 31.7 | 0.55 |
| SECONDARY EQ-5D Scores |
85.0; 82.0; 1.0; 1.0; 85.0; 85.0 | 0.037 sig |
| SECONDARY Assessment of Trade-off Between Disease-free Survival and Quality of Life. |
— | — |
| SECONDARY Statistical Modeling of Genomic Biomarkers |
— | — |
Eligibility Criteria
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
- PSA evaluated at least 10 days after prostate biopsy
- For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
- For patients who received dutasteride, PSA evaluated at least 90 after completion 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
Data sourced from ClinicalTrials.gov (NCT00331773) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.