Clinical trial · Interventional
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
NCT00715104CI-TRIAL-00017770NeoACTcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sipuleucel-T with Booster | Biological | — | UNRESOLVED |
| Sipuleucel-T without Booster | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sipuleucel-T with Booster
- 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.
- interventionNames
- Biological: Sipuleucel-T with Booster
- type
- EXPERIMENTAL
- label
- Sipuleucel-T without Booster
- description
- Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
- interventionNames
- Biological: Sipuleucel-T without Booster
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSheikh 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. PMID 27216195