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Recruiting NCT06134232

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

Phase II Interventional Metastatic Castration-Resistant Prostate Cancer (mCRPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sipuleucel-T Injection.
Who it may be relevant to
Registry conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

Overview

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

Detailed description

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Interventions

  • Drug Sipuleucel-T Injection
    Single Infusion

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T [Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period]
  • Evaluate Overall Survival [Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating]

Eligibility criteria

Inclusion criteria

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

  • Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
  • Have qualified for on-label PROVENGE® infusion
  • Have received all 3 infusions of PROVENGE® prior to randomization
  • Written informed consent provided prior to the initiation of study procedures
  • Estimated life expectancy ≥12 months

Exclusion criteria

A subject will not be eligible for participation in this study if any of the following criteria apply.

  • Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
  • Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
  • Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
  • On experimental or investigational therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 31 centers
  • Arizona Urology Specialists — Tuscon
  • City of Hope - National Medical Center — Duarte
  • Urology Associates of Central California Medical Group — Fresno
  • Unio Health Partners - Genesis Research, LLC — San Diego
  • Colorado Urology — Lakewood
  • Advanced Urology Institute — Daytona Beach
  • Advanced Urology Institute — Largo
  • Advanced Urology Institute — Ocala
  • … and 23 more centers

Identifiers

NCT: NCT06134232 · P23-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗