Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

Part of paid clinical trials in Tucson, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04530552
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Localized Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.

Key Dates

Start date
Jul 23, 2021
Status verified
May 2026
Primary completion
Nov 6, 2024
Completion
Jan 31, 2027

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment (apalutamide)
    Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.

Primary Outcome Measure

Change in Prostate Specific Antigen (PSA) Levels [ Time Frame: Baseline to end-of-intervention (mean 4.8 weeks; up to 9 weeks) ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - Prevention Research ClinicTucsonArizona85719-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
George Washington University Medical CenterWashington D.C.District of Columbia20037-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
NCI - Center for Cancer ResearchBethesdaMaryland20892-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center - Prevention Research Clinic· Tucson, AZUSC / Norris Comprehensive Cancer Center· Los Angeles, CAGeorge Washington University Medical Center· Washington D.C., DCJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDNCI - Center for Cancer Research· Bethesda, MD

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