Trial · NCT06100705
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
NCT06100705, Phase 2, Recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC. Trials, record NCT06100705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06100705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
- NCT number
- NCT06100705
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Testosterone Cypionate, Sipuleucel-T
- First posted
- 2023-10-25
- Last updated
- 2026-09-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the immune response to PA2024 with BAT and Sipuleucel-T | Through the study completion, average 12 months | As measured by ELISPOT from blood samples in pg/ml |
| Secondary | To determine antigen presenting cell (APC) cumulative activation | Through the study completion, average 12 months | as assessed by flow cytometry staining and defined as the increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on after culture versus before culture cells from the sipuleucel-T product from blood samples in pg/ml |
| Secondary | To determine APC number | Through the study completion, average 12 months | as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml |
| Secondary | To determine total nucleated cell count | Through the study completion, average 12 months | as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml |
| Secondary | To determine T cell proliferation to PA2024 | Through the study completion, average 12 months | As measured by ELISPOT from blood samples in pg/ml |
| Secondary | To determine T cell proliferation to Prostatic Acid Phosphatase (PAP) | Through the study completion, average 12 months | As assessed by tritiated thymidine uptake from blood samples |
| Secondary | To determine ex vivo cytokine profiles with BAT + Sipuleucel-T | Through the study completion, average 12 months | As assessed via Luminex assay from blood samples in pg/ml |
| Secondary | To determine humeral response with BAT + Sipuleucel-T | Through the study completion, average 12 months | As assessed by ELISA from blood samples in pg/ml |
| Secondary | To determine PSA50 response rate to BAT + Sipuleucel-T | Through the study completion, average 12 months | As defined by PSA decline \> 50% from baseline at any point |
| Secondary | To determine objective response rate (ORR) to BAT + Sipuleucel-T | Through the study completion, average 12 months | As defined by RECIST v1.1 criteria |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06100705
GET https://conductscience.org/api/trials/v1/NCT06100705/registered