Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
This study is currently recruiting participants.
Verified August 2012 by Dana-Farber Cancer Institute
Sponsor:
Dana-Farber Cancer Institute
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: August 22, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Docetaxel Drug: Androgen Hormonal Suppression and Radiation Drug: Androgen Suppression Therapy and Radiation Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine if overall survival is increased [ Time Frame: 2014 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Androgen Suppression Therapy and Radiation therapy
|
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
|
|
Experimental: 2
Docetaxel plus androgen suppression therapy and radiation therapy
|
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
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116142
Contacts
| Contact: Anthony V D'Amico, MD, PHD | 617-732-8821 | |
| Contact: Marian J Loffredo, RN,BS,OCN | 617-355-7264 |
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium) | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Marian J. Loffredo, RN, BS, OCN 617-732-7264 | |
| Contact: Anthony V. D'Amico, MD, PHD 617-732-8821 | |
| Principal Investigator: Anthony V. D'Amico, MD, PHD | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sanofi
Investigators
| Principal Investigator: | Anthony V. D'Amico, MD, PhD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00116142 History of Changes |
| Other Study ID Numbers: | 05-043 |
| Study First Received: | June 27, 2005 |
| Last Updated: | August 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Prostate Cancer Hormone Refractory Metastatic |
Localized Locally Advanced Prostate Cancer - High Risk Localized or Locally Advanced |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens |
Docetaxel Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013