Phase 3
N=612
Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00288080 ↗Enrolled (actual)
612
Serious AEs
19.7%
Results posted
Jan 2017
Primary outcome: Primary: Overall Survival — 88.7; 93.3 percentage of participants — p=0.0398
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Prednisone (Drug); docetaxel (Drug); Oral antiandrogen (Drug); Radiation therapy (Radiation); LHRH agonist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
88.7; 93.3 | 0.0398 sig |
| SECONDARY Biochemical Control |
82.0; 84.1 | 0.22 |
| SECONDARY Local Control |
99.2; 99.5 | — |
| SECONDARY Distant Metastasis |
2.6; 1.9 | 0.21 |
| SECONDARY Disease-free Survival |
73.0; 78.5 | 0.0484 sig |
| SECONDARY Incidence of Adverse Events |
14.9; 2.1; 48.4; 25.9; 26.0; 40.1 | — |
| SECONDARY The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level |
— | — |
| SECONDARY Validity of PSA Endpoint as a Surrogate for Overall Survival |
— | — |
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
- Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
- Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2
- Gleason score 8, PSA 20-150 ng/mL, and any T stage
- Gleason score 7, PSA 20-150 ng/mL, and any T stage
- Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
- Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
- Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
- PSA ≤ 150 ng/mL
- Cannot have been obtained during any of the following time points:
- 10-day period after prostate biopsy
- After initiation of hormonal therapy
- Within 30 days after discontinuation of finasteride
- Within 90 days after discontinuation of dutasteride
- No distant metastases by physical exam and bone scan
- Equivocal bone scan findings allowed if plain films are negative
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,800/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
- No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
- 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 intravenous antibiotics
- No AIDS
- No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
- No existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
- At least 90 days since prior testosterone
- Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
- No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
- No prior systemic chemotherapy for prostate cancer
- Prior chemotherapy for a different cancer is allowed
- No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
- Intensity modulated radiotherapy allowed
Data sourced from ClinicalTrials.gov (NCT00288080). 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.