Trial · NCT06496581
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
NCT06496581, Phase 3, Recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders). Trials, record NCT06496581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06496581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
- NCT number
- NCT06496581
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 500 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
- Prostate Cancer Metastatic
- Interventions
- 177Lu-PMSA-617, Standard of Care
- First posted
- 2024-07-11
- Last updated
- 2024-12-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to death due to any cause, up to 8.5 years | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. |
| Primary | Radiographic progression-free survival (rPFS) | From randomization to radiographic progression or death, up to 8.5 years | Radiographic progression-free survival (rPFS) is defined as the time from randomization to the date of radiographic progression according to PCWG3 criteria by investigator assessment, or death, whichever occurs first. |
| Secondary | Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS) | From randomization to onset of castration-resistance or death, up to 8.5 years | Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS) is defined as the time from randomization to the onset of castration-resistance or death from any cause, whichever occurs first. |
| Secondary | Prostate Cancer-Specific Survival (PCSS) | From the date of randomization to a PCSS event, up to 8.5 years | Prostate Cancer-Specific Survival (PCSS) is defined as the time from the date of randomization to the date of death due to prostate cancer. |
| Secondary | PSA response | From baseline over the treatment period, up to 8.5 years | PSA response will be assessed by the maximum change of PSA (rise or fall) from baseline over the treatment period. A complete PSA response is defined by an undetectable level of serum PSA. |
| Secondary | Skeletal-related event-free survival (SRE-FS) | From randomization to the onset of a SRE-FS event, up to 8.5 years | Skeletal-related event-free survival (SRE-FS) is defined as the time from the randomization date to the date of diagnosis of either a skeletal-related event (SRE) (fracture, or bone pain requiring radiation therapy, or spinal cord compression, or preventive surgery to the bones) or death, whichever occurs first. |
| Secondary | Time to severe urinary event (SUE) | From randomization to the onset of a SUE event, up to 8.5 years | Time to severe urinary event (SUE) is defined as the time from the randomization date to the date of diagnosis of either one of the following SUE, whichever occurs first: urinary retention with need for a urinary catheter, suprapubic catheter, double J stent, nephrostomy, treatment of the prostate by radiotherapy or trans-urethral resection of the prostate (TURP) or prostatectomy done to relieve patients with local symptoms. |
| Secondary | Time to initiation of first subsequent anti-cancer systemic therapy for CRPC (TTSST1) | From randomization to initiation of the first anti-cancer systemic therapy for CRPC, up to 10 years | TTSST1 is defined as the time from the randomization date to the date of initiation of the first anti-cancer systemic therapy for CRPC. |
| Secondary | Time to initiation of second subsequent anti-cancer systemic therapy for CRPC (TTSST2) | From randomization to initiation of the second anti-cancer systemic therapy for CRPC, up to 10 years | TTSST2 is defined as the time from the randomization date to the date of initiation of the second anti-cancer systemic therapy for CRPC. |
| Secondary | Efficacy of first subsequent anti-cancer systemic therapy for CRPC | From first anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years | Efficacy of subsequent anti-cancer systemic therapy for CRPC will be defined as the time from first anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT06496581
GET https://conductscience.org/api/trials/v1/NCT06496581/registered