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

NCTNCT01250717Other id2001P-001577Other idE-99-0363-FB

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 28 participants (actual)
Sponsor: Beth Israel Deaconess Medical Center · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2001
Primary completion: May 2011
Completion: May 2011
First posted: 1 Dec 2010 (estimated)
Last update posted: 4 Feb 2014 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200220042006200820102012

Ph 2
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
NCT01250717
Jan 2001 to May 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DocetaxelDrug
DexamethasoneDrug
EstramustineDrug
ZoladexDrug
CasodexDrug
Radical ProstatectomyProcedure

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists
Time frame · status post prostectomy
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· status post prostectomy

Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists

Group	Value (participants)
Docetaxel Followed by Radical Prostatectomy	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Docetaxel Followed by Radical ProstatectomyThis is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below. Docetaxel Followed by Radical Prostatectomy Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy Zoladex : Given subcutaneously for 4 doses every three months Casodex : Taken orally once a day for 6 months Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle 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	–	5 / 28	0 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.