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

• Status: Not yet recruiting
• Trial end date: 2032-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dendreon

Criteria

Inclusion Criteria:

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

1. 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).

2. Have qualified for on-label PROVENGE® infusion

3. Have received all 3 infusions of PROVENGE® prior to randomization

4. Written informed consent provided prior to the initiation of study procedures

5. 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.

1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).

2. Need for systemic chronic immunosuppressive therapy (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids).

3. 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.

4. On experimental or investigational therapy.

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