Phase 3
N=2,028
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00002597 ↗Enrolled (actual)
2,028
Serious AEs
2.4%
Results posted
Jun 2017
Primary outcome: Primary: Overall Survival Rate (10-year) — 61.9; 56.8 percentage of patients — p=0.0309
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- flutamide (Drug); Zoladex (Drug); Lupron (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Rate (10-year) |
61.9; 56.8 | 0.0309 sig |
| SECONDARY Disease-specific Survival Rate (10 Years) |
95.7; 92.6 | 0.001 sig |
| SECONDARY Local Progression Rate (10 Years) |
10.9; 16.1 | 0.0013 sig |
| SECONDARY Distant Failure Rate (10 Years) |
5.5; 8.0 | 0.035 sig |
| SECONDARY Biochemical Failure Rate (10 Years) |
26.3; 41.1 | <0.001 sig |
| SECONDARY Clinical Relapse Rate (10 Years) |
15.0; 21.7 | <0.001 sig |
| SECONDARY Second Biochemical Relapse Rate (10 Years) |
2.7; 6.1 | <0.001 sig |
| SECONDARY Disease-free Survival Rate (10 Years) |
51.7; 39.5 | <0.001 sig |
| SECONDARY Positive Re-biopsy Rate at Two Years |
20.2; 38.9 | <0.001 sig |
Summary
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
Eligibility Criteria
Inclusion criteria
- Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b.
- Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0).
- Karnofsky performance status ≥ 70.
- PSA is mandatory, must be ≤ 20)
- No prior hormonal therapy, radiation or chemotherapy.
- Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization.
- Prior testosterone administration allowed if at least 90 days elapsed since last administration.
- No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman.
- Treatment begins within 21 days after randomization.
- Patients signs a study-specific informed consent form.
- Alanine Aminotransferase (ALT) within 2x upper normal limits.
Exclusion criteria
- Stage T1a or ≥ T2c disease.
- Lymph node involvement (N1 - N3).
- Evidence of distant metastasis. (M1)
- PSA > 20.
- Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy.
- Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma.
Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Karnofsky performance status of < 70.
Data sourced from ClinicalTrials.gov (NCT00002597). 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.