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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

NCTNCT00500110 (opens ClinicalTrials.gov in a new tab)Other idID03-0112
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
39 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2003
Primary completion
Feb 2010
Completion
Feb 2010
First posted
12 Jul 2007 (estimated)
Last update posted
28 Apr 2015 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200620082010
  1. Ph 2

    Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

    NCT00500110

    Jun 2003 to Feb 2010

Registry summary

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

Primary Objective: 1\. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer. Secondary Objectives: 1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer. 2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.

Interventions

  • DocetaxelDrug
  • Imatinib MesylateDrug
  • LeuprolideDrug
  • Goserelin AcetateDrug

Arms1

  • Experimental

    Hormonal Ablation, Imatinib + Docetaxel

    Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Achieving Pathological Complete Response

    Time frame · Every 3 months for 1 year, then every 6 months until disease progression or death

    Registry description

    Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.

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· Every 3 months for 1 year, then every 6 months until disease progression or death

Number of Participants Achieving Pathological Complete Response

GroupValue (participants)
Treatment0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Hormonal Ablation, Imatinib + DocetaxelImatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months–9 / 3636 / 36

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2009

Neoadjuvant platelet derived growth factor receptor inhibitor therapy combined with docetaxel and androgen ablation for high risk localized prostate cancer.

Mathew et al. 2009The Journal of urologycited by 30

PMID 19012911DOI 10.1016/j.juro.2008.09.006PUB-19012911

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included. * All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy. * All patients must have at least one of the following high-risk features: clinical or pathological T3 disease, or cT2c or PSA\>20ng/ml or Gleason 8-10 adenocarcinoma or clinical T2b and PSA\>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed. * Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted. * Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \>/= 1,500/mm3 and platelet count of \>/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of \</= 1.5 mg/dl and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance \>/= 40 cc/min (measured or calculated). * Patients must sign a written informed consent form prior to treatment. All patients must have a surgical and medical oncology consult prior to signing informed consent. Exclusion Criteria: * Patients with small cell or sarcomatoid prostate cancers are not eligible. * Patients with clinical or radiological evidence of metastatic disease * Prior chemotherapy or experimental agents * Patients with severe intercurrent infection. * Patients with The New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or myocardial infarction (MI) in the last 6 months. * Contraindications to corticosteroids. * Uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (HIV) infection. * Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years. * Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.

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