Clinical trial NCT00715104: Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Official title: An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2008-07-15
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
timeFrame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Secondary outcomes:
measure: Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
timeFrame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
measure: Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
timeFrame: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
measure: Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
timeFrame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
measure: Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
timeFrame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
measure: Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
timeFrame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
measure: Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
timeFrame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
measure: Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
timeFrame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
measure: Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
timeFrame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Portland
country: United States
facility: Kaiser Permanente Portland
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Dendreon
name: Andy Sandler, MD
role: STUDY_DIRECTOR
References:
citation: Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.