Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

This study is currently recruiting participants.
Verified April 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00116142
First received: June 27, 2005
Last updated: April 16, 2014
Last verified: April 2014

June 27, 2005
April 16, 2014
June 2005
January 2015   (final data collection date for primary outcome measure)
To determine if overall survival is increased [ Time Frame: 2014 ] [ Designated as safety issue: No ]
To determine if overall survival is increased
Complete list of historical versions of study NCT00116142 on ClinicalTrials.gov Archive Site
To determine if PSA doubling time is prolonged; To determine if PSA failure is decreased; To determine if cancer specific mortality is decreased [ Time Frame: 2014 ] [ Designated as safety issue: No ]
To determine if PSA doubling time is increased; To determine if PSA failure is decreased; To determine if cancer specific mortality is decreased
Not Provided
Not Provided
 
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
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

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.

Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Docetaxel
    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.
    Other Name: Taxotere
  • Drug: Androgen Hormonal Suppression and Radiation
    Total Androgen Ablation and external beam radiation therapy
  • Drug: Androgen Suppression Therapy and Radiation Therapy
    Total Androgen Ablation and External Beam Radiation Therapy
  • 1
    Androgen Suppression Therapy and Radiation therapy
    Interventions:
    • Drug: Androgen Hormonal Suppression and Radiation
    • Drug: Androgen Suppression Therapy and Radiation Therapy
  • Experimental: 2
    Docetaxel plus androgen suppression therapy and radiation therapy
    Intervention: Drug: Docetaxel
Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. 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. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
June 2019
January 2015   (final data collection date for primary outcome measure)

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.
Male
30 Years and older
No
Contact: Anthony V D'Amico, MD, PHD 617-732-8821
Contact: Marian J Loffredo, RN,BS,OCN 617-732-8821
United States
 
NCT00116142
05-043
Yes
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Sanofi
Principal Investigator: Anthony V. D'Amico, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP