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

Dendreon

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Treatments: Drug: Sipuleucel-T Injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06134232

P23-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 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)
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Booster Arm

Experimental group

Description:

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.

Treatment:

Drug: Sipuleucel-T Injection

No Booster

No Intervention group

Description:

No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.