Trial · NCT05733351
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
NCT05733351, Phase 1, Terminated, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer. Trials, record NCT05733351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05733351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
- NCT number
- NCT05733351
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Interventions
- Abiraterone, Biospecimen Collection, Bone Scan, Computed Tomography, Docetaxel, Enzalutamide, FDG-Positron Emission Tomography, Magnetic Resonance Imaging, PSMA PET Scan, Vudalimab
- First posted
- 2023-02-17
- Last updated
- 2025-09-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Up to 70 days post treatment | Will be assessed using the National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 5.0 where, Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number. |
| Primary | Radiographic Progression-Free Survival | Up to 3 years | Will be assessed per Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as outlined in Prostate Cancer Working Group 31 (soft tissue to be assessed by RECIST 1.1, and bone disease to be assessed by Prostate Cancer Working Group 3) by radiologic evaluation. PSA response rate: PSA decline greater than or equal to 50% from baseline up to 24 weeks from treatment initiation. |
| Secondary | Objective Response Rate | Up to 3 years | Will be summarized with the 2-sided 95% CI using the Clopper-Pearson method. Kaplan-Meier methods will be used to estimate median survival time or time-specific survival rate with a 95% confidence interval for rPFS or a time-to-event outcome. |
| Secondary | PSA Response Rate | Baseline up to 24 weeks from treatment initiation | PSA decline \>= 50% and will be calculated along with 95% exact confidence intervals. The fold change of the numbers of CD8 T-cells or other tumor-specific T-cells before and after treatment will be described by summary statistics (mean, median, Q1, Q3, standard deviation). |
| Secondary | PSA undetectable rate | Baseline up to 24 weeks from treatment initiation | PSA undetectable rate will be assessed by PSA \< 0.2 ng/mL up to 24 weeks from treatment initiation. Will be estimated with the Kaplan-Meier method with time-specific rate estimated with 95%CI. |
| Secondary | Duration of response | Up to 3 years | Will be assessed per PCWG-modified RECIST 1.1 and calculated along with 95% exact confidence intervals. |
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 |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 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/NCT05733351
GET https://conductscience.org/api/trials/v1/NCT05733351/registered