Trial · NCT07219147
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT07219147, Phase 1, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT07219147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07219147
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT07219147
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 30 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Interventions
- Biospecimen Collection, Bone Scan, Computed Tomography, Leukapheresis, Lutetium Lu 177 Vipivotide Tetraxetan, Magnetic Resonance Imaging, PSMA PET Scan, Sipuleucel-T
- First posted
- 2025-10-21
- Last updated
- 2026-04-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody response rate | Between week 7 and week 19 | Will be defined as the proportion of patients with an IgG titer \> 400. Comparisons between study arms will be performed using the Fisher's exact test. Descriptive statistics will be used to summarize the antibody response rates, and Clopper-Pearson exact 95% confidence intervals will be calculated. |
| Primary | Change in anti-PAP IgG antibody titers | Between week 7 and week 19 | Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate. |
| Secondary | Change in anti-PA2024 antibody titers | Between week 7 and week 19 | Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate. |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study treatment | Comparison of toxicities will be assessed using Common Terminology Criteria for Adverse Events version (v) 5.0 criteria. |
| Secondary | Proportion of patients achieving a ≥ 50% reduction in prostate specific antigen (PSA) levels (PSA50 response rate) | At baseline up to 3 years | The PSA50 response rate will be calculated for each treatment arm as the proportion of patients achieving PSA50 response among all evaluable patients. A Fisher's exact test will be used to compare response rates between arms. |
| Secondary | Objective response rate | Up to 3 years | The association between treatment arm and overall response as per RECIST v 1.1 criteria (response observed versus not observed) will be examined using Fisher's exact test. |
| Secondary | Radiographic progression-free survival (rPFS) | From enrollment to progression or death from any cause, assessed up to 3 years | Will be evaluated using Prostate Cancer Clinical Trial Working Group 3 and RECIST v 1.1 criteria. The median rPFS will be estimated using the Kaplan-Meier method. |
| Secondary | Overall survival | From enrollment to death from any cause, assessed up to 3 years | Will be estimated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT07219147
GET https://conductscience.org/api/trials/v1/NCT07219147/registered