Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT02721979
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Prostate Adenocarcinoma
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Apalutamide — DRUGGiven PO
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Quality-of-Life Assessment — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
Study Details
This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.
Key Dates
- Start date
- Nov 2, 2017
- Status verified
- Feb 2023
- Primary completion
- Feb 12, 2020
- Completion
- Nov 30, 2021
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (apalutamide)Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Negative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate [ Time Frame: At 90 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | - |
Find similar trials in Seattle, WA
Related Studies
- Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE TrialPHASE3 · Recruiting · NRG Oncology · Phoenix, Arizona
- Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC StudyPHASE2 · Recruiting · University of Washington · Pittsburgh, Pennsylvania
- Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET ImagingPHASE3 · Recruiting · ECOG-ACRIN Cancer Research Group · Anchorage, Alaska
- Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene MutationPHASE2 · Recruiting · SWOG Cancer Research Network · Anchorage, Alaska