NCT00870714

Brief Summary

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic analysis will be performed with the first and second cycle of therapy. All patients will be evaluated for toxicity, tumor response, and recurrence.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

6 years

First QC Date

July 24, 2008

Last Update Submit

March 25, 2009

Conditions

Prostate Cancer

Keywords

Prostate CancerNeoadjuvant

Outcome Measures

Primary Outcomes (1)

  • To determine the pathologic response rate of neoadjuvant therapy with the combination of docetaxel and ketoconazole given to patients who are at a high risk of recurrence of prostate cancer.

    One year

Secondary Outcomes (1)

  • To assess in preliminary fashion whether of this treatment will decrease the incidence of biochemical recurrence and provide a survival benefit as compared to patients with local treatment only or other adjuvant therapies.

    One Year

Study Arms (1)

A

EXPERIMENTAL

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection

Drug: DocetaxelDrug: Ketoconazole

Interventions

DocetaxelDRUG

Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.

A
KetoconazoleDRUG

Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.

A

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically proven adenocarcinoma of the prostate.
  • Patients must meet at least one of the following high risk criteria:
  • PSA \> 20
  • Gleason score 8 or greater
  • Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy core
  • Greater than 50% of cores at time of biopsy positive for cancer
  • Clinical Stage T3 Disease
  • Patients must have PS of 0-1(ECOG) and medically deemed a surgical candidate for radical prostatectomy.
  • Age \> or = to 18.
  • Patients with a pre-existing peripheral neuropathy of equal to or greater than grade two are ineligible.
  • Serum Creatinine must be \< or equal to 2.0mg/dl.
  • Patients must currently not receiving any drug which is metabolized by cytochrome P450-3A4 including the statins, cyclosporin, terfenadine and erythromycin.
  • Prior to receiving any dose of docetaxel, patients should have absolute neutrophil counts \> 1,500, hemoglobin \> 8.0 g/dl and platelet counts \> 100,000/mm3.
  • Patients with bilirubin elevated above institutional upper limit of normal (ULN)must be excluded. Transaminases (SGOT and/or SGPT) may be up to 5.0 x institutional upper limit of normal (ULN) if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 5 x ULN if transaminases are \< ULN. However, patients who have both transaminase elevation \> 1.5 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study (due to decrease clearance of docetaxel and increased risk of toxicity).
  • Patients receiving concurrent warfarin are eligible but require monitoring of protime on a weekly basis.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VAMC

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelKetoconazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 24, 2008

First Posted

March 27, 2009

Study Start

September 1, 2004

Primary Completion

September 1, 2010

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

US(1)