Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01250717
• Recruitment Status: Completed
• First Posted: December 1, 2010
• Results First Posted: February 4, 2014
• Last Update Posted: February 4, 2014
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Walter Reed Army Medical Center
• Information provided by (Responsible Party): Glenn Bubley, MD, Dana-Farber Cancer Institute

Study Description

Brief Summary:

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Docetaxel; Drug: Dexamethasone; Drug: Estramustine; Drug: Zoladex; Drug: Casodex; Procedure: Radical Prostatectomy	Phase 2

Detailed Description:

• Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
• After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
• At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
• Study Start Date: January 2001
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm

Intervention/treatment

Experimental: Docetaxel Followed by Radical Prostatectomy; Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy

Drug: Docetaxel; Given by an IV infusion over 1 hour on day 2 of a three-week cycle; Other Name: Taxotere; Drug: Dexamethasone; Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel; Other Name: Decadron; Drug: Estramustine; Taken orally three times a day for 5 days for the first part of every three week cycle; Drug: Zoladex; Given subcutaneously for 4 doses every three months; Other Name: goserelin acetate; Drug: Casodex; Taken orally once a day for 6 months; Other Name: Bicalutamide; Procedure: Radical Prostatectomy; after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Outcome Measures

Primary Outcome Measures :

1. Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists [ Time Frame: status post prostectomy ]
   One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate
• Potential candidate for radical prostatectomy
• Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive
• ECOG Performance Status 0-1
• WBC > 3,000 ul
• HCT > 30%
• PLT > 100,000/ul
• LFTS within normal limits

Exclusion Criteria:

• Prior hormones, radiation or chemotherapy for prostate cancer
• Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year
• Evidence of active infection
• Significant peripheral neuropathy

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Walter Reed Army Medical Center

Investigators

• Principal Investigator: Glenn J. Bubley, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Glenn Bubley, MD, Director Of Genitourinary Oncology @ Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT01250717
• Other Study ID Numbers: 2001P-001577; E-99-0363-FB ( Other Identifier: BIDMC IRB )
• First Posted: December 1, 2010
• Results First Posted: February 4, 2014
• Last Update Posted: February 4, 2014
• Last Verified: August 2012

Keywords provided by Glenn Bubley, MD, Dana-Farber Cancer Institute:

prostatectomy; docetaxel

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Dexamethasone; Goserelin; Estramustine; Docetaxel; Bicalutamide; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Androgen Antagonists; Hormone Antagonists; Antineoplastic Agents, Alkylating; Alkylating Agents