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

NCT01250717 | Completed Phase 2 Results DMC

• 2 other identifiers: 2001P-001577E-99-0363-FB
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostatectomy; docetaxel

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Docetaxel Followed by Radical Prostatectomy

EXPERIMENTAL

Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy

Drug: Docetaxel; Drug: Dexamethasone; Drug: Estramustine; Drug: Zoladex; Drug: Casodex; Procedure: Radical Prostatectomy

Interventions

Docetaxel DRUG

Given by an IV infusion over 1 hour on day 2 of a three-week cycle

Also known as: Taxotere

Docetaxel Followed by Radical Prostatectomy

Dexamethasone DRUG

Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel

Also known as: Decadron

Docetaxel Followed by Radical Prostatectomy

Estramustine DRUG

Taken orally three times a day for 5 days for the first part of every three week cycle

Docetaxel Followed by Radical Prostatectomy

Zoladex DRUG

Given subcutaneously for 4 doses every three months

Also known as: goserelin acetate

Docetaxel Followed by Radical Prostatectomy

Casodex DRUG

Taken orally once a day for 6 months

Also known as: Bicalutamide

Docetaxel Followed by Radical Prostatectomy

Radical Prostatectomy PROCEDURE

after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Docetaxel Followed by Radical Prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Walter Reed Army Medical Center: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Dexamethasone; Calcium Dobesilate; Estramustine; Goserelin; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Although this study has the longest median follow-up periods reported (80 months or 6.6 years), the overall number of participants is too few to make strong judgements about efficacy

Results Point of Contact

• Title: Glenn Bubley MD, Director of GU ONC
• Organization: BIDMC

gbubley@bidmc.harvard.edu

617-735-2062

Study Officials

• Glenn J. Bubley, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Of Genitourinary Oncology @ Beth Israel Deaconess Medical Center

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: December 1, 2010
• Study Start: January 1, 2001
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 4, 2014
• Results First Posted: February 4, 2014

Record last verified: 2012-08

Locations

US (1)