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Phase 2 N=28 Treatment

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01250717 ↗
Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Feb 2014
Primary outcome: Primary: Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists — 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Docetaxel (Drug); Dexamethasone (Drug); Estramustine (Drug); Zoladex (Drug); Casodex (Drug); Radical Prostatectomy (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Beth Israel Deaconess Medical Center
Primary completion
May 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists		 — —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01250717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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