Clinical trials: Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
- Condition Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
- Funder type Industry (pharma, biotech, devices)
PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT07311694
- Testing
- HRS-4357 injection, Enzalutamide；Abiraterone
- Where
- China
- Volunteers
- 370 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
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
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as…
- Trial name
- NCT07226986
- Testing
- AMO959, AAA617, Enzalutamide
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or…
- Trial name
- NCT07236112
- Testing
- Intravenous (IV) single dose
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- C Ray Therapeutics
Prostate Cancer
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic…
- Trial name
- AcTFirst (NCT06855277)
- Testing
- AAA817, ARPI, Standard of Care
- Where
- 106 sites in United States, Australia and 10 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan
The purpose of this study is to assess the efficacy, tolerability, safety, pharmacokinetic (PK) and dosimetry of 177Lu-PSMA-617, in participants with progressive prostate-specific membrane antigen (PSMA)-positive metastatic…
- Trial name
- NCT05114746
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, Best supportive/best standard of care
- Where
- 8 sites in Japan
- Volunteers
- 94 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer
A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC
177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA.
- Trial name
- NCT06383052
- Testing
- 177Lu-NYM032 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Norroy Bioscience Co., LTD
Castration-Resistant Prostatic Cancer
Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT06033001
- Testing
- [Lu-177]-PNT2002
- Where
- 7 sites in United States
- Sponsor
- Lantheus Medical Imaging
Metastasis From Malignant Tumor of Prostate (Disorder)
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
- Trial name
- NCT05653856
- Testing
- 64Cu-PSMA I&T
- Where
- 9 sites in United States
- Volunteers
- 26 people
- Sponsor
- Curium US LLC
Metastatic Castration-resistant Prostate Cancer, mCRPC
The Safety and Dosimetry Study of 177Lu-LNC1003 Injection
This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. In the clinical development, we aim to demonstrate the following: 1.
- Trial name
- NCT06237491
- Testing
- 177Lu-LNC1003 Injection group 1, 177Lu-LNC1003 Injection group 2, 177Lu-LNC1003 Injection group 3
- Volunteers
- 12 people
- Sponsor
- Yantai LNC Biotechnology Singapore PTE. LTD.
Metastatic Castration-resistant Prostate Cancer
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA…
- Trial name
- AlphaBreak (NCT06402331)
- Testing
- FPI-2265
- Where
- 18 sites in United States
- Volunteers
- 110 people
- Sponsor
- Fusion Pharmaceuticals Inc.
Prostate Cancer
Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with…
- Trial name
- NCT07795268
- Testing
- 177Lu-NYM032 injection, Best supportive/best standard of care
- Volunteers
- 600 people
- Sponsor
- Norroy Bioscience Co., LTD
Advanced and/or Metastatic Solid Tumours
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and preliminary…
- Trial name
- POTENTIA (NCT04839991)
- Testing
- CB307
- Where
- 20 sites in United States, Netherlands and 2 more
- Volunteers
- 70 people
- Sponsor
- Crescendo Biologics Ltd.
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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
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…
- Trial name
- NCT05658003
- Testing
- [177Lu]Lu-PSMA-617, ARDT, [68Ga]Ga-PSMA-11
- Where
- 15 sites in China
- Volunteers
- 63 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor…
- Trial name
- NCT06520345
- Testing
- 177Lu-TLX591, Enzalutamide, Abiraterone
- Where
- 33 sites in United States, Australia and 4 more
- Volunteers
- 520 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Prostate Cancer
A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC
The purpose of this study is to evaluate safety and tolerability, pharmacokinetics （PK）, efficacy of TRC003 injection in patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor…
- Trial name
- NCT07567521
- Testing
- Radiopharmaceuticals
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- C Ray Therapeutics
Prostatic Cancer, Castration-Resistant
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617)…
- Trial name
- NCT07047118
- Testing
- JSB462, AAA617
- Where
- 44 sites in United States, Australia and 13 more
- Volunteers
- 138 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasm
177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer…
- Trial name
- PROter (NCT03490838)
- Testing
- 177Lu-PSMA-R2
- Where
- 11 sites in United States, Spain
- Volunteers
- 27 people
- Sponsor
- Advanced Accelerator Applications
Oligometastatic Prostate Cancer (OMPC)
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary…
- Trial name
- PSMA-DC (NCT05939414)
- Testing
- AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg)
- Where
- 144 sites in United States, Argentina and 25 more
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and…
- Trial name
- PSMAndARPI (NCT06894511)
- Testing
- AAA617, ARPI: Abiraterone, ARPI: Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Clinical Evaluation of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer （mCRPC）
This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT07660211
- Testing
- 177Lu-PSMA-VG01
- Where
- China
- Volunteers
- 10 people
- Sponsor
- VitsGen Therapeutics Inc.