Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05751941
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Abiraterone — DRUG
    1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
  • Enzalutamide — DRUG
    160 mg of Enzalutamide will be given orally daily ending at week 4
  • Apalutamide — DRUG
    240 mg of Apalutamide will be given orally daily ending at week 4
  • Sipuleucel-T — DRUG
    Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.

Study Details

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.

Key Dates

First listed
Mar 2, 2023
Start date
Feb 14, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Sipuleucel-T with NHA
    Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
  • Experimental: Sipuleucel-T without NHA
    Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.

Primary Outcome Measure

Cumulative APC Activation [ Time Frame: At Week 4 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Tampa, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Moffitt Cancer Center· Tampa, FLOhio State University Comprehensive Cancer Center· Columbus, OH

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