Phase 3
N=350
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00116142 ↗Enrolled (actual)
350
Serious AEs
43.5%
Results posted
Jul 2021
Primary outcome: Primary: 10-Year Restricted Mean Survival Time for Overall Survival — 8.82; 9.11 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Docetaxel (Drug); Androgen Hormonal Suppression and Radiation (Drug); Androgen Suppression Therapy and Radiation Therapy (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10-Year Restricted Mean Survival Time for Overall Survival |
8.82; 9.11 | — |
| SECONDARY 10-year Biochemical Recurrence (PSA Failure) |
48; 54 | — |
| SECONDARY 10-year Prostate Cancer Mortality |
11; 15 | — |
| SECONDARY Number of Participants With Acute Adverse Events |
18; 46 | — |
| SECONDARY Number of Participants With Late Adverse Events, Any Grade and Attribution |
128; 140 | — |
Summary
This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven prostate cancer
- Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive
- Negative bone scan
- Lymph node assessment by CT or MR
- Adequate hematologic function (Blood Counts)
- Adequate liver functions (blood tests)
- ECOG performance Status 0 or 1
- Peripheral neuropathy must be =< grade 1
- PSA obtained within 3 months of entry
Exclusion Criteria
- Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
- Prior pelvic radiation therapy
- Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
- Individuals unable to tolerate lying still 5 - 10 minutes
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
Data sourced from ClinicalTrials.gov (NCT00116142). 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.