A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
NCT06516510 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-09-25
Summary
A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
Conditions
Interventions
- DRUG
-
lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Radiopharmaceutical
Sponsors & Collaborators
-
Medpace, Inc.
collaborator INDUSTRY -
Blue Earth Therapeutics Ltd
lead INDUSTRY
Principal Investigators
-
Blue Earth Therapeutics · Blue Earth Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-31
- Primary Completion
- 2025-08-15
- Completion
- 2025-08-15
- FDA Drug
- Yes
Countries
- United States
- Netherlands
- Spain
Study Locations
More Related Trials
-
Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer
NCT07093801 ·Status: RECRUITING
-
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
NCT06894511 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
NCT06449781 ·Status: RECRUITING ·Phase: PHASE2
-
177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC
NCT03545165 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
NCT05849298 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
NCT03490838 ·Status: TERMINATED ·Phase: PHASE1
-
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
NCT06517719 ·Status: RECRUITING
-
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
NCT05939414 ·Status: RECRUITING ·Phase: PHASE3
-
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
NCT07200830 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
NCT06216249 ·Status: RECRUITING ·Phase: PHASE2
-
Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy
NCT03042312 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
NCT07226986 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT07219147 ·Status: RECRUITING ·Phase: PHASE1
-
Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
NCT04886986 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
NCT04343885 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer
NCT05383079 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
NCT06531499 ·Status: RECRUITING ·Phase: PHASE1
-
177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer
NCT04663997 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
NCT06288113 ·Status: RECRUITING ·Phase: PHASE2
-
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
NCT06145633 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT07047118 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
NCT05983198 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer
NCT03874884 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
NCT05682443 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer
NCT05567770 ·Status: WITHDRAWN ·Phase: PHASE1