Trial · NCT06100705
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | To estimate radiographic progression free survival (rPFS) | From the date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 5 years | Defined as the time interval from registration to the first occurrence of radiographic progression by Tc99 Bone Scan using PCWG3 criteria or radiographic soft tissue progression by RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | To estimate overall survival (OS) | From the date of registration until the date of death from any cause, assessed up to 5 years | Defined as the time interval from registration to death due to any cause |
| Secondary | To assess safety and tolerability to BAT+ Sipuleucel-T | Through the study completion, average 12 months | As assessed by using CTCAE version 5.0 |
| Secondary | To explore potential blood-based and tissue-based biomarkers of treatments response and resistance | At screening, at End of Treatment (blood-based biomarker only), and at Disease Progression (tissue-based biomarker only) | Blood-based biomarkers will be assessed by next-generation sequencing. Tissue-based biomarkers will be assessed by biopsy of metastasis at the time of clinically suspected or radiographic disease progression if deemed safe and recommended by the PI. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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