Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer (NeoACT)

Dendreon

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: Sipuleucel-T with Booster; Biological: Sipuleucel-T without Booster

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00715104

P07-1

Details and patient eligibility

About

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Full description

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adenocarcinoma of the prostate.
• Subject is scheduled for RP as the initial therapy for localized prostate cancer.
• Subject is ≥ 18 years of age.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has adequate hematologic, renal, and liver function.

Exclusion criteria

• Subject has any evidence of metastasis.
• Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
• Subject has received prior radiation therapy or chemotherapy for prostate cancer.
• Subject has received systemic steroid therapy within 14 days.
• Subject has a history of stage III or greater cancer, excluding prostate cancer.
• Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
• Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Sipuleucel-T with Booster

Experimental group

Description:

Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.

Treatment:

Biological: Sipuleucel-T with Booster

Sipuleucel-T without Booster

Experimental group

Description:

Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.

Treatment:

Biological: Sipuleucel-T without Booster