Trial · NCT05658003
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
NCT05658003, Phase 2, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer. Trials, record NCT05658003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05658003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
- NCT number
- NCT05658003
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Interventions
- [177Lu]Lu-PSMA-617, ARDT, [68Ga]Ga-PSMA-11, Best supportive care
- First posted
- 2022-12-20
- Last updated
- 2026-03-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic progression free survival (rPFS) | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1 as assessed by blinded independent central review, or death. |
| Secondary | Overall survival (OS) | From date of randomization until date of death from any cause, assessed up to 47 months (estimated final analysis) | Overall survival (OS) is defined as the time from the date of enrollment to the date of death due to any cause. If a participant is not known to have died, then OS will be censored at the latest date the participant was known to be alive (on or before the cut-off date). |
| Secondary | Progression Free Survival (PFS) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first documented progression by investigator assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first. |
| Secondary | Prostate-specific antigen 50 response rate | Week 12, Week 24, Week 48 | PSA 50 response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of \>= 50% from baseline that is confirmed by a second consecutive PSA measurement \>= 4 weeks later. Determination of response status will be based on PCWG3 recommendations. |
| Secondary | Time to a first symptomatic skeletal event (TTSSE) | From date of randomization till date of death from any cause, whichever happens first, assessed up to 47 months (estimated final analysis) | Time to a first symptomatic skeletal event (TTSSE) is defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first. |
| Secondary | Time to Prostate Specific Antigen (PSA) progression | From date of randomization till date of Prostate Specific Antigen (PSA) progression, assessed up to 47 months (estimated analysis) | Time to PSA Progression (TTPSAP) defined as time from randomization to PSA progression. PSA progression date is defined as the date of 1) \>= 25% increase and \>= 2 ng/mL above the nadir, confirmed by a second value \>= 3 weeks later if there is a PSA decline from baseline, or 2) \>= 25% increase and \>= 2ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline: |
| Secondary | Time to chemotherapy (TTCT) | From date of randomization until date of subsequent chemotherapy or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Time to chemotherapy (TTCT) defined as time from randomization to initiation of the first subsequent chemotherapy or death, whichever occurs first. |
| Secondary | Overall response rate (ORR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Overall response rate (ORR)is defined as the proportion of participants with best overall response of complete response or partial response in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1 |
| Secondary | Disease control rate (DCR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1 |
| Secondary | Time to response (TTR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Time to response (TTR) is defined as the time from the date of randomization to the date of first documented response (CR or PR, which must be confirmed subsequently). CR and PR are based on tumor response data as per BICR and according to PCWG3-modified RECIST v1.1. Participants who did not achieve a confirmed CR or PR will be censored at the last adequate tumor assessment date when they did not have a PFS event or at maximum follow-up (i.e. FPFV to LPLV used for the analysis) when they did have a PFS event. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT05658003
GET https://conductscience.org/api/trials/v1/NCT05658003/registered