Phase 3
Completed N=1,532
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Source: ClinicalTrials.gov NCT00033631 ↗Enrolled (actual)
1,532
Serious AEs
4.9%
Results posted
Feb 2017
Primary outcomePrimary: Overall Survival — 88.5; 88.1 percentage of participants — p=0.98
◆ Published Evidence
Highly cited
122citations · ~6 / year
Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields.
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.
Linked Publications (5)
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Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields.
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Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer.
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Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial.
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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 Overall Survival |
88.5; 88.1 | 0.98 |
| SECONDARY Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition |
40.2; 25.2 | <0.0001 sig |
| SECONDARY Disease Specific Survival |
1.4; 0.8 | 0.14 |
| SECONDARY Local Progression |
3.5; 1.8 | 0.0001 sig |
| SECONDARY Distant Metastases |
3.1; 2.2 | 0.051 |
| SECONDARY Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity |
18.8; 21.0 | 0.29 |
| SECONDARY Percentage of Participants With Erectile Disfuction at 12 Months |
38.06; 49.66 | 0.0513 |
| SECONDARY Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months |
91; 91; 366; 331; 90; 95 | 0.59 |
| SECONDARY Quality Adjusted Survival by SQLI |
— | — |
| SECONDARY Tumor Control Probability |
— | — |
| SECONDARY Normal Tissue Complication Probability |
— | — |
Eligibility Criteria
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
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 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 phytoestrogen preparation (PC-SPES)
Data sourced from ClinicalTrials.gov (NCT00033631) 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.