Phase 3
N=397
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00004054 ↗Enrolled (actual)
397
Serious AEs
19.1%
Results posted
Jan 2015
Primary outcome: Primary: Overall Survival (5-year Rate Reported) — 84.9; 87.2 percentage of participants — p=0.81
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bicalutamide (Drug); estramustine phosphate sodium (Drug); etoposide (Drug); flutamide (Drug); paclitaxel (Drug); Luteinizing hormone releasing hormone [LHRH] agonist (Drug); Radiation therapy (Radiation); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (5-year Rate Reported) |
84.9; 87.2 | 0.81 |
| SECONDARY Rate of Biochemical Failure at 5 Years |
48.0; 47.9 | 0.82 |
| SECONDARY Rate of Local Progression at 5 Years |
5.8; 4.1 | 0.09 |
| SECONDARY Rate of Distant Metastasis at Five Years |
10.4; 8.3 | 0.42 |
| SECONDARY Disease-free Survival Rate at 5 Years |
39.1; 42.9 | 0.61 |
Summary
RATIONALE: Hormones can stimulate the production 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
- Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)
- Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL
- Negative lymph nodes
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Zubrod 0 or 1
Life expectancy:
- Not specified
Hematopoietic:
- White blood cell (WBC) count of at least 3,000/mm^3
- Platelet count at least 130,000/mm^3
- Hemoglobin at least 11.4 g/dL
Hepatic:
- Aspartate aminotransferase (AST) no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
Other:
- No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer
- No major medical or psychiatric illness that would preclude study participation
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 5 years since prior chemotherapy
Endocrine therapy:
- At least 60 days since prior finasteride for prostatic hypertrophy
- At least 90 days since prior testosterone
- No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer
Radiotherapy:
- No prior pelvic radiotherapy
- No concurrent intensity-modulated radiotherapy
Surgery:
- No prior radical prostatectomy
- No prior cryosurgery for prostate cancer
- No prior orchiectomy
Data sourced from ClinicalTrials.gov (NCT00004054). 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.