Trial · NCT06220188
PSMA-RLT in Biochemically Recurrent PCa
NCT06220188, Phase 2, Recruiting, Medical University of Vienna
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PSMA-RLT in Biochemically Recurrent PCa. Trials, record NCT06220188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06220188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PSMA-RLT in Biochemically Recurrent PCa
- NCT number
- NCT06220188
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Medical University of Vienna
- Conditions
- Prostate Cancer Recurrent
- Interventions
- [177Lu]Lu-PSMA I&T
- First posted
- 2024-01-23
- Last updated
- 2024-02-13
- Other registries' IDs
- eudract:2022-003713-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PSA response | 12 months | in term of PSA decline of ≥ 50% from baseline value |
| Primary | Emergence of therapy toxicity | 12 months | in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased \<8.0 g/dL; \<4.9 mmol/L; \<80 g/L; platelet count decreased \<50,000 - 25,000/mm3; \<50.0 - 25.0 x 10e9 /L and white blood cell decreased \<2000 - 1000/mm3; \<2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased \> 3.0 x baseline or \>3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased \>5.0 - 20.0 x ULN if baseline was normal or \>5.0 - 20.0 x baseline if baseline was abnormal; albumin \<2 g/dL or \<20 g/L; bilirubin increased \>3.0 - 10.0 x ULN if baseline was normal or \>3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased \> ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
| Secondary | Time to PSA value progression | 18 months | to evaluate progression free survival |
| Secondary | androgen deprivation therapy- and other treatment-free survival | 18 months | analyze the time until the start of androgen deprivation therapy |
| Secondary | Evaluation of life quality of the treated patients | 18 months | Using the questionnaires: FACT-P, EORTC QLQ |
| Secondary | Assess time to imaging progression | 18 months | In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1. |
| Secondary | Quantification of circulating free tumor DNA | 18 months | Quantification of circulating free tumor DNA (ctDNA), enumeration of circulating tumor cells (CTCs) before and following \[177Lu\]Lu-PSMAI\&T-RLT and analyse molecular changes in liquid biopsy markers following \[177Lu\]Lu-PSMAI\&T-RLT. |
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/NCT06220188
GET https://conductscience.org/api/trials/v1/NCT06220188/registered