Trial · NCT06388369
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
NCT06388369, Phase 1, Phase 2, Terminated, University Hospital, Essen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer. Trials, record NCT06388369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06388369
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
- NCT number
- NCT06388369
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University Hospital, Essen
- Conditions
- Very High Risk Prostate Carcinoma
- Interventions
- [177Lu]Lu-PSMA-617, Ipilimumab
- First posted
- 2024-04-29
- Last updated
- 2026-03-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility to perform prostatectomy on time | During the intervention/procedure | Feasibility will be defined as the ability to perform prostatectomy in at least 75% of the Analysis population 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks. A treatment arm will be deemed not feasible in the actual study if \>25% of patients of that arm required a delay of surgery \>3 weeks. |
| Primary | Clinical activity: Proportion of participants in the full analysis set who achieve a pCR | After surgery | The proportion of participants in the full analysis set who achieve a pathological complete response (pCR). The assessment of pCR will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted. The proportion of participants in the full analysis set who achieve a MRD. The assessment of MRD will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted. |
| Secondary | Safety Profile of neoadjuvant treatment before radical prostatectomy | Start of neoadjuvant treatment up to 1 year after surgery | Characterizing the safety profile of neoadjuvant treatment with Ipilimumab and \[177Lu\]Lu-PSMA-617 RLT before radical prostatectomy according to AEs and SAEs measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. |
| Secondary | Safety Profile of neoadjuvant treatment before radical prostatectomy | Start of neoadjuvant treatment up to 1 year after surgery | Measures of PSA progression-free survival for up to 1 year after prostatectomy. |
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.
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/NCT06388369
GET https://conductscience.org/api/trials/v1/NCT06388369/registered