Phase 2
N=42
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00715104 ↗Enrolled (actual)
42
Serious AEs
14.3%
Results posted
Apr 2015
Primary outcome: Primary: 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 — 2.33; 2.03; 1.98; 6.39 cells/μm2 — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sipuleucel-T with Booster (Biological); Sipuleucel-T without Booster (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dendreon
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2.33; 2.03; 1.98; 6.39 | 1.000 |
| SECONDARY 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 |
0.93; 0.43; 0.74; 3.83 | 1.000 |
| SECONDARY 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 |
0.65; 0.94; 0.88; 2.87 | 0.002 sig |
| SECONDARY Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood |
4.9; 56.6; 26.5; 52.3 | <0.001 sig |
| SECONDARY Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood |
2.2; 13.3; 2.0; 12.8 | 0.173 |
| SECONDARY Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood. |
35.6; 25.6; 23.5; 18.0 | 0.667 |
| SECONDARY Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood. |
9.2; 0.3; 6.2; 0.4 | 0.086 |
| SECONDARY Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups |
35.6; 81.7; 25.6; 22.3; 23.5; 19.5 | 0.950 |
| SECONDARY Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups |
9.2; 20.2; 0.3; 4.8; 6.2; 2.7 | 0.048 sig |
Summary
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
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.
Data sourced from ClinicalTrials.gov (NCT00715104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.