Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT01990196
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • degarelix — DRUG
    Every 4-week Treatment: A starting dose of 240 mg of Degarelix is taken subcutaneously (SQ) -placed under the skin by injection- the first month. Doses continue every 4 weeks at 80 mg SQ. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician.
  • enzalutamide — DRUG
    Once Daily Treatment: A starting dose of 160 mg of Enzalutamide is taken by mouth once daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician.
  • trametinib — DRUG
    Once Daily Treatment: If randomized into Group 2, then 2mg of Trametinib is taken by mouth daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician
  • dasatinib — DRUG
    Once Daily Treatment: If randomized into Group 3, then 100mg of Dasatinib is taken by mouth daily. Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician

Study Details

Prostate cancer is the most common cancer in men and the second leading cause of cancer death in men. The purpose of this research study is to compare prostate cancers treated with hormone therapy versus prostate cancers treated with hormone therapy plus drugs that directly target cancer cells.

Key Dates

Start date
Sep 23, 2014
Status verified
Aug 2025
Primary completion
Sep 23, 2024
Completion
Sep 30, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AR inhibition only
    AR inhibition only Group 1: degarelix + enzalutamide Endocrine therapy with degarelix and enzalutamide will continue for a minimum of 6 weeks and a maximum of 8 weeks in all groups prior to the planned prostatectomy.
  • Active Comparator: AR inhibition plus MEK inhibition
    AR inhibition plus MEK inhibition Group 2: trametinib + degarelix + enzalutamide In Group 2, treatment with trametinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, trametinib will be administered for no less than two weeks and no more than four weeks.
  • Active Comparator: AR inhibition plus SRC inhibition
    AR inhibition plus SRC inhibition Group 3: dasatinib + degarelix + enzalutamide In Group 3, treatment with dasatinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, dasatinib will be administered for no less than two weeks and no more than four weeks.

Primary Outcome Measure

N-cadherin and vimentin expression [ Time Frame: Prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, Los Angeles· Los Angeles, CA

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