Trial Outcomes & Findings for Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer (NCT NCT01250717)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

status post prostectomy

Results posted on

2014-02-04

Participant Flow

Between September 28, 1999 and May 17, 2005, 28 participants with high risk localized prostate cancer were enrolled on this IRB approved phase II protocol from BIDMC Urology clinics

This was a single arm study and there were no arms. Participants were screened for final eligibility after consent was completed. All enrolled subjects were treated

Participant milestones

Participant milestones
Measure	Docetaxel Followed by Radical Prostatectomy This 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
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel Followed by Radical Prostatectomy n=28 Participants This 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years FULL_RANGE NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Docetaxel Followed by Radical Prostatectomy n=28 Participants This 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
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists	0 participants

Adverse Events

Docetaxel Followed by Radical Prostatectomy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel Followed by Radical Prostatectomy n=28 participants at risk This 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
Blood and lymphatic system disorders neutropenic fever	14.3% 4/28 • Number of events 4 • 6 months followed for four cycles of therapy
Hepatobiliary disorders elevated liver functions	3.6% 1/28 • Number of events 1 • 6 months followed for four cycles of therapy

Other adverse events

Adverse event data not reported

Additional Information

Glenn Bubley MD, Director of GU ONC

BIDMC

Phone: 617-735-2062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place