CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
Docetaxel +2 moredrug
Likely dose
Docetaxel 60 mg/m² intravenously every 3 weeks for 3 cycles, followed by docetaxel 20 mg/m² weekly for 7 weeks during radiation therapyAI-extracted
Key inclusion· 8
  • Biopsy-proven prostate cancer with high-risk features: T1b/T1c/T2a with PSA >10 or Gleason ≥4+3=7 or PSA velocity >2.0 ng/ml/year; OR T2c/T3a/T3b/T4; OR Gleason ≥3+4=7 with ≥50% positive cores; OR any Gleason 5 tertiary component
  • Negative bone scan
  • Lymph node assessment by CT or MR imaging performed
  • ECOG performance status 0 or 1
Key exclusion· 5
  • Prior history of malignancy within 5 years, except in-situ cancers unlikely to affect life expectancy
  • Prior pelvic radiation therapy
  • Prior hormonal therapy, except if ≤4 weeks prior to enrollment
  • Unable to tolerate lying still for 5-10 minutes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116142
NCT00116142Phase 3Completed

Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial

Dana-Farber Cancer Institute·interventional·Posted Jun 28, 2005·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating Docetaxel, Androgen Hormonal Suppression and Radiation, and 1 other intervention for Prostate Cancer. Completed, enrolled 350 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2005
Enrollment StartJun 1, 2005
Primary CompletionJun 29, 2020
TodayJul 2, 2026
Enrollment to primary: 15.1 yearsPosted 21.0 years ago

Interventions

Docetaxeldrug

60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Androgen Hormonal Suppression and Radiationdrug

Total Androgen Ablation and external beam radiation therapy

Androgen Suppression Therapy and Radiation Therapydrug

Total Androgen Ablation and External Beam Radiation Therapy