Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

Conditions

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sipuleucel-T Injection — DRUG
  Single Infusion

Study Details

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Key Dates

Start date

Oct 2, 2023

Status verified

Aug 2025

Primary completion

Dec 31, 2031

Completion

Jun 30, 2032

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Booster Arm
  Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events.
• No Intervention: No Booster
  No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.

Primary Outcome Measure

Assess humoral immune response to PAP and PA2024 after booster infusion [ Time Frame: Once all subjects have completed the study through the 5 year Overall Survival Period ]

Central Contacts

• Margaret Warner-Lubin
  2064588358
  [email protected]

Locations (31)

Find similar trials in Tuscon, AZ

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