Phase 3
N=1,579
Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00005044 ↗Enrolled (actual)
1,579
Serious AEs
15.5%
Results posted
Oct 2017
Primary outcome: Primary: Disease-specific Survival (DSS) (10-year Rates Reported) — 95; 96 percentage of participants — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Casodex (Drug); Eulexin (Drug); LHRH agonist (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-specific Survival (DSS) (10-year Rates Reported) |
95; 96 | 0.45 |
| SECONDARY Overall Survival (OS) (10-year Rates Reported) |
66; 67 | 0.62 |
| SECONDARY Disease-free Survival (DFS) (10-year Rates Reported) |
24; 23 | 0.47 |
| SECONDARY Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) |
6; 4; 6; 6 | 0.07 |
| SECONDARY Time to First Biochemical Failure (BF) (10-year Rates Reported) |
56; 59; 27; 27 | 0.74 |
| SECONDARY Time to Second Biochemical Failure (SBF) (10-year Rates Reported) |
10; 9 | 0.62 |
| SECONDARY Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient) |
30.8; 19.5; 41.6; 49.8; 16.1; 25.7 | — |
Summary
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date.
- Zubrod Performance Status 0-1 (Appendix II).
- Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization.
- Patients at intermediate risk for disease relapse as determined by any of the following combinations of factors (NOTE: tumor found in one or both lobes on biopsy, but not palpable, will not alter T stage):
- Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen >10 but ≤ 100.
- Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen 100.
- Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of <10 years.
- Any of the following prior therapies:
- Pelvic external beam radiation therapy.
- Radionuclide prostate brachytherapy.
- Prostatectomy or prostatic cryosurgery.
- Prior bilateral orchiectomy.
- Prior androgen suppression therapy; however, patients begun on LHRH agonist therapy remain eligible if (1) LHRH agonists were started no more than 30 days before randomization, and (2) Casodex or Eulexin was (or will be) started no more than 14 days before or after the date that the LHRH agonist injection was given. Any finasteride therapy administered for prostatic hypertrophy must be discontinued.
- Chemotherapy for prostatic carcinoma.
- Previous or concomitant invasive cancer, other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5 years.
- Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.
- The patient's participation in another medical research study that involves prostate cancer treatment.
Data sourced from ClinicalTrials.gov (NCT00005044). 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.