Trial · NCT06259123
Neoadjuvant PSMA-RLT in Oligometastatic PCa
NCT06259123, Phase 2, Recruiting, Medical University of Vienna
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant PSMA-RLT in Oligometastatic PCa. Trials, record NCT06259123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06259123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant PSMA-RLT in Oligometastatic PCa
- NCT number
- NCT06259123
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Medical University of Vienna
- Conditions
- Prostate Cancer
- Interventions
- [177Lu]Lu-PSMA I&T
- First posted
- 2024-02-14
- Last updated
- 2024-02-15
- Other registries' IDs
- eudract:2022-004115-92
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy | 12 months | Using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Furthermore, regular estimation of patient's ability to perform their usual everyday activities using Karnofsky performance status scale that ranges between a maximum of 100 percent (no restrictions) and 0 percent (death) and Eastern Cooperative Oncology Group Status scale that ranges from 0 (complete health) to 5 (death). |
| Secondary | PSA response to neoadjuvant PSMA-RLT and radical prostatectomy | 24 months | in term of PSA decline of ≥ 50% from baseline value |
| Secondary | Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy | 24 months | in terms of disappearance of PSMA-avid lesions and/or size regression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1. |
| Secondary | Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy, | 24 months | estimate the time until the start of any therapy- and androgen deprivation therapy |
| Secondary | Estimate time to castration-resistant prostate cancer | 24 months | estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy |
| Secondary | Evaluate pathologic response at radical prostatectomy | 24 months | measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis. |
| Secondary | Quantification of circulating free tumor DNA (ctDNA) | 24 months | enumeration of circulating tumor cells (CTCs) during the study period, molecular changes measured in liquid biopsy markers and tissue specimens following PSMA-RLT and radical prostatectomy and during follow-up. |
| Secondary | Assess quality of life under the systemic PSMA-RLT | 24 months | using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P). |
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/NCT06259123
GET https://conductscience.org/api/trials/v1/NCT06259123/registered