Phase 3
Completed N=350
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Source: ClinicalTrials.gov NCT00116142 ↗Enrolled (actual)
350
Serious AEs
43.5%
Results posted
Jul 2021
Primary outcomePrimary: 10-Year Restricted Mean Survival Time for Overall Survival — 8.82; 9.11 years
◆ Published Evidence
Established
25citations · ~2 / year
Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial.
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.
Linked Publications (4)
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Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial.
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Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial.
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Elective Pelvic Lymph Node Radiation Therapy and the Risk of Death in Patients With Unfavorable-Risk Prostate Cancer: A Postrandomization Analysis.
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Risk of Short-Term Prostate-Specific Antigen Recurrence and Failure in Patients With Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.