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NCT Number: NCT01250717

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

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

Other names: Taxotere

Dexamethasone

Drug

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

Other names: Decadron

Estramustine

Drug

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

Zoladex

Drug

Given subcutaneously for 4 doses every three months

Other names: goserelin acetate

Casodex

Drug

Taken orally once a day for 6 months

Other names: Bicalutamide

radical prostatectomy

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Walter Reed Army Medical Center

Registry information

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2010
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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