Trial · NCT06866938
Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
NCT06866938, Phase 2, Recruiting, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer. Trials, record NCT06866938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06866938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
- NCT number
- NCT06866938
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 58 participants, estimated
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- [177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
- First posted
- 2025-03-10
- Last updated
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival rate | At 24 weeks after the start of study treatment | Proportion (in %) of patients alive without disease progression at 24 weeks. Progression is defined by imaging (bone scan and CT-scan) according to RECIST 1.1 and/or PCWG3 criteria. |
| Secondary | Imaging-based radiographic progression (rPFS) | Through study completion, a maximum of 57 months | Imaging-based radiographic progression defined as the time from the first cycle of re-treatment to the date of radiographic disease progression or death from any cause. |
| Secondary | Overall survival | Through study completion, a maximum of 57 months | Overall Survival (Os) defined as the time from the first cycle of re-treatment to the date of death from any cause |
| Secondary | Objective response rate | Through study completion, a maximum of 57 months | Objective response rate (ORR) (Complete Response (CR) + Partial Response (PR)) measured by RECIST v1.1 response. |
| Secondary | Duration of response | Through study completion, a maximum of 57 months | Duration of response (DOR) will be measured in patients who achieved a CR or PR between the date of first response and the date of RECIST progression or death. |
| Secondary | Disease Control Rate | Through study completion, a maximum of 57 months | Disease control rate as measured by RECIST v1.1 response. Rates will be measured in soft tissue, lymph nodes and visceral lesions. |
| Secondary | Progression free survival | Through study completion, a maximum of 57 months | Progression free survival will be defined as the date of first cycle of \[177Lu\]Lu-PSMA-617 re-treatment to the date of first evidence of radiographic progression, clinical progression, PSA progression, or death from any cause, whichever occurs first. |
| Secondary | Biological response | Through study completion, a maximum of 57 months | Proportion of participants with a PSA response defined as a patient who has achieved a ≥ 50% PSA decrease from baseline that is confirmed with a second PSA measurement at ≥ 4 weeks. |
| Secondary | Time to PSA progression | Through study completion, a maximum of 57 months | Time to PSA progression will be defined as the date from first cycle of \[177Lu\]Lu-PSMA-617 re-treatment to a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir and confirmed by a second consecutive value obtained 3 or more weeks later. Where no decline from baseline is documented, PSA progression is defined as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment. |
| Secondary | Safety : Adverse Events | Through study completion, a maximum of 57 months | Safety of re-treatment will be assessed by percentage of patients with all grade and Serious AEs; percentage of patients with SAEs during the active follow up period; percentage of patients with an interruption of \[177Lu\]Lu-PSMA-617 re-treatment; Percentage of patients who discontinue \[177Lu\]Lu-PSMA-617 re-treatment secondary to an AEs or death; Number and grade of AE related to the investigational medicinal product or to the procedures added by the research |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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/NCT06866938
GET https://conductscience.org/api/trials/v1/NCT06866938/registered