Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT05658003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2022-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-label, Multi-center, Randomized, Phase II Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of \[177Lu\]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic castration-resistant prostate cancer patients, who were previously treated with another ARDT as last treatment and who have not been exposed to a taxane-containing regimen in castrate resistant prostate cancer (CRPC) or hormone-sensitive prostate cancer (HSPC) settings and who are considered appropriate for delaying taxane-based chemotherapy. The primary endpoint of rPFS will be assessed via blinded independent centralized review of radiographic images provided by the treating physician and as outlined in Prostate Cancer Working Group 3 (PCWG3) guidelines.
Detailed Description:
The study contains a screening period to assess the eligibility of participants, only participants fulfilling the \[68Ga\]Ga-PSMA-11 PET scan interpretation criteria for eligibility and meeting all other inclusion/exclusion criteria will be enrolled. In the randomization period, approximately 60 participants will be randomized 1:1 to receive \[177Lu\]Lu-PSMA-617 treatment or a change of approved ARDT treatment. Randomization will be stratified by symptomatology i.e., Asymptomatic or mildly symptomatic vs. symptomatic.
Participants randomized to \[177Lu\]Lu-PSMA-617 treatment group will receive 7.4 GBq (200 mCi) ± 10% \[177Lu\]Lu-PSMA-617 once every 6 weeks (± 1 week) for 6 cycles. For participants randomized to the ARDT treatment arm, the change of ARDT treatment for each participant will be selected by the treating physician prior to randomization and will be administered per the physician's orders. Supportive care will be allowed in both arms at the discretion of the investigator. ARDT must not be administrated concomitantly with \[177Lu\]Lu-PSMA-617.
Efficacy assessment will be performed every 8 weeks after first dose of study treatment for the first 24 weeks (week 9, 17, 25) and then every 12 weeks (week 37, 49, etc) until confirmation of radiographic progression by BICR. Upon confirmation of rPFS by BIRC, participants randomized to ARDT arm will be allowed to crossover to \[177Lu\]Lu-PSMA-617 treatment if the crossover criteria are met. Post-treatment follow up period will have a 30-day safety follow up post EOT visit and long term survival follow up.
Participants randomized to \[177Lu\]Lu-PSMA-617 treatment group will receive 7.4 GBq (200 mCi) ± 10% \[177Lu\]Lu-PSMA-617 once every 6 weeks (± 1 week) for 6 cycles. For participants randomized to the ARDT treatment arm, the change of ARDT treatment for each participant will be selected by the treating physician prior to randomization and will be administered per the physician's orders. Supportive care will be allowed in both arms at the discretion of the investigator. ARDT must not be administrated concomitantly with \[177Lu\]Lu-PSMA-617.
Efficacy assessment will be performed every 8 weeks after first dose of study treatment for the first 24 weeks (week 9, 17, 25) and then every 12 weeks (week 37, 49, etc) until confirmation of radiographic progression by BICR. Upon confirmation of rPFS by BIRC, participants randomized to ARDT arm will be allowed to crossover to \[177Lu\]Lu-PSMA-617 treatment if the crossover criteria are met. Post-treatment follow up period will have a 30-day safety follow up post EOT visit and long term survival follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: