Clinical trial · Observational
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
NCT01306890CI-TRIAL-00038992PROCEEDcompletedResults 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)
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sipuleucel-T | Biological | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- sipuleucel-T
- interventionNames
- Biological: sipuleucel-T
Primary outcomes (1)
- measure
- To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
- timeFrame
- Every 3 months for a minimum of 3 years
- description
- The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Secondary outcomes (1)
- measure
- Survival
- timeFrame
- Every 3 months for a minimum of 3 years
- description
- To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * subjects must be at least 18 years of age * subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment * subjects must understand and sign an informed consent form Exclusion Criteria: * none
References
Publications (2)
- DERIVEDWei XX, Kwak L, Hamid A, He M, Sweeney C, Flanders SC, Harmon M, Choudhury AD. Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: experience at Dana Farber and in the PROCEED Registry. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):314-319. doi: 10.1038/s41391-022-00493-x. Epub 2022 Feb 10. PMID 35145218
- DERIVEDSartor O, Armstrong AJ, Ahaghotu C, McLeod DG, Cooperberg MR, Penson DF, Kantoff PW, Vogelzang NJ, Hussain A, Pieczonka CM, Shore ND, Quinn DI, Small EJ, Heath EI, Tutrone RF, Schellhammer PF, Harmon M, Chang NN, Sheikh NA, Brown B, Freedland SJ, Higano CS. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis. 2020 Sep;23(3):517-526. doi: 10.1038/s41391-020-0213-7. Epub 2020 Feb 28. PMID 32111923