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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

Overview

Status
Terminated
Phase
Phase 2
Enrollment
1 participants (actual)
Sponsor
Noah Hahn, M.D. · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2009
Primary completion
Dec 2010
Completion
Dec 2010
First posted
12 Mar 2009 (estimated)
Last update posted
14 Mar 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 2

    Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

    NCT00860158

    Mar 2009 to Dec 2010

    Terminated

Registry summary

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

This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.

Interventions

  • DasatinibDrug
  • Leuprolide Acetate (LHRH Analogue)Drug
  • Radical ProstatectomyProcedure

Arms1

  • Experimental

    Single Arm Assignment

    Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To Estimate the Pathologic Complete Response (pCR) Rate

    Time frame · 18 months

Secondary outcomes(5)
  1. To Estimate Partial Pathologic Responses (pPR)

    Time frame · 18 months

  2. To Estimate PSA Response Rate

    Time frame · 18 months

  3. To Estimate Progression Free Survival

    Time frame · 18 months

  4. To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers

    Time frame · 18 months

  5. To Estimate Safety and Tolerability of LHRH Plus Dasatinib

    Time frame · 18 months

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 outcome· 18 months

To Estimate the Pathologic Complete Response (pCR) Rate

GroupValue
Single Arm Assignmentnot posted
Secondary and other outcome results(5)
Secondary outcome· 18 months

To Estimate Partial Pathologic Responses (pPR)

GroupValue
Single Arm Assignmentnot posted
Secondary outcome· 18 months

To Estimate PSA Response Rate

GroupValue
Single Arm Assignmentnot posted
Secondary outcome· 18 months

To Estimate Progression Free Survival

GroupValue
Single Arm Assignmentnot posted
Secondary outcome· 18 months

To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers

GroupValue
Single Arm Assignmentnot posted
Secondary outcome· 18 months

To Estimate Safety and Tolerability of LHRH Plus Dasatinib

GroupValue
Single Arm Assignmentnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Single Arm AssignmentNeoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.–0 / 11 / 1

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. * Clinical stage T1-T3a disease. * Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis. * Kattan pre-operative nomogram-predicted (based on stage, Prostate Specific Antigen (PSA) and Gleason score) 5-year risk of recurrence-free survival of 80% or less * Must be deemed eligible for radical prostatectomy. * Must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. * Written informed consent and HIPAA authorization for release of personal health information. * Age \> 18 years at the time of consent. Exclusion Criteria: * No evidence of regional, lymph node or distant metastasis on clinical or radiological assessments. All baseline radiology studies must be performed within 28 days prior to registration for protocol therapy. * No prior malignancy in the past 2 years except for basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), and colonic polyp with focus of adenocarcinoma) can be enrolled after approval from the Sponsor Investigator. * No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.), prior LHRH agonist therapy (leuprolide, goserelin acetate, etc.), or prior orchiectomy are ineligible. * No prior systemic chemotherapy or radiotherapy for prostate cancer is allowed. Transurethral resection of the prostate for benign prostatic hypertrophy (BPH) and oral alpha-blockers (terazosin, tamsulosin, doxazosin) are permitted. * No history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy. * No history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) * No history of diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of registration on protocol therapy. * No history of ongoing or recent (≤ 3 months of registration on protocol therapy) significant gastrointestinal bleeding * No ongoing anti-coagulation and/or anti-platelet therapies allowed. * No unresolved pleural or pericardial effusion of any grade within 3 months of registration for protocol therapy. * No uncontrolled angina, congestive heart failure or MI within 6 months prior to registration for protocol therapy. * No diagnosed congenital long QT syndrome. * No history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes). * No prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec) * Following medications must be discontinued at least 7 days prior to registration for protocol therapy and be withheld for the duration of dasatinib therapy: * Drugs that are generally accepted to have a risk of causing Torsades de Pointes * Patient must not be receiving any prohibited CYP3A4 inhibitors /inducers/ substrates * Anti-coagulation and/or anti-platelet therapies - to avoid potential bleeding risks. * No major surgical procedure, open biopsy, or significant trauma within 28 days prior to registration for protocol therapy. * Ability to comply with study and/or follow-up procedures and requirements. * No treatment with any investigational agent for any medical condition within 28 days prior to registration for protocol therapy. * No clinically significant infections or any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive the study drug. * Ability to take oral medication (dasatinib must be swallowed whole). * No known history of hypokalemia that cannot be corrected prior to registration on protocol therapy. * No known history of hypomagnesemia that cannot be corrected prior to registration on protocol therapy.

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