Trial · NCT05867615
Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:
NCT05867615, Phase 2, Active not recruiting, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:. Trials, record NCT05867615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05867615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:
- NCT number
- NCT05867615
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Conditions
- Cancer
- Interventions
- [177Lu]Lu-PSMA I&T
- First posted
- 2023-05-22
- Last updated
- 2025-12-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute toxicity rate | 40 months | safety is evaluated according to version 5.0 of Common Terminology Criteria for Adverse Events (CTCAE). Safety is defined as the percentage of patients who experience acute toxicity grade3/grade4 from the 1st treatment until 30 days after the last treatment cycle. |
| Primary | disease control rate (DCR) | 40 months | is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) or no progression of disease for prostate cancer (according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria) at the 1st planned evaluation |
| Secondary | progression-free survival (PFS) | 68 months | PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression (according to RECIST 1.1 or Prostate Cancer Clinical Trials Working Group (PCWG3) criteria for prostate cancer patients) or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation. |
| Secondary | overall survival (OS) | 68 months | Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off. |
| Secondary | late toxicity | 68 months | The late toxicity is the toxicity that occurred after 30 days from the last treatment administration up to 6 months. |
| Secondary | PET/CT response | 68 months | PET/CT response is based on Standardized Uptake Value (SUV). PET/CT response will be evaluated with descriptive statistics. |
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/NCT05867615
GET https://conductscience.org/api/trials/v1/NCT05867615/registered