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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250717
• Other study ID #: 2001P-001577
• Secondary ID: E-99-0363-FB
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2010
• Last updated: December 16, 2013
• Start date: January 2001
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
Given by an IV infusion over 1 hour on day 2 of a three-week cycle
• Dexamethasone
Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel
• Estramustine
Taken orally three times a day for 5 days for the first part of every three week cycle
• Zoladex
Given subcutaneously for 4 doses every three months
• Casodex
Taken orally once a day for 6 months

Procedure:
• Radical Prostatectomy
after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists	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.	status post prostectomy	No