Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
NCT07208240 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-10-06
Summary
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
Conditions
- High Risk Prostate Cancer
Interventions
- DRUG
-
Tb-PSMA-I&T (Tb-PSMA)
Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy
Sponsors & Collaborators
-
Rabin Medical Center
lead OTHER
Principal Investigators
-
Shay Golan, MD · Rabin Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-12
- Primary Completion
- 2028-08-12
- Completion
- 2028-08-12
Countries
- Israel
Study Locations
More Related Trials
-
Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
NCT02280356 ·Status: COMPLETED ·Phase: PHASE2
-
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
NCT01859689 ·Status: WITHDRAWN ·Phase: PHASE2
-
Prostate Resection After Microwave Ablation (PRAMA)
NCT06128525 ·Status: COMPLETED ·Phase: NA
-
177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
NCT03805594 ·Status: COMPLETED ·Phase: PHASE1
-
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
NCT02597894 ·Status: WITHDRAWN ·Phase: NA
-
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
NCT00002602 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
NCT03541850 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
NCT02048150 ·Status: COMPLETED ·Phase: PHASE1
-
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer
NCT04870567 ·Status: UNKNOWN ·Phase: NA
-
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
NCT06388369 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
NCT00091390 ·Status: COMPLETED ·Phase: PHASE2
-
Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy
NCT02699424 ·Status: COMPLETED ·Phase: NA
-
Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
NCT03413137 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
NCT05924672 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Radiation Therapy in Treating Patients With Prostate Cancer
NCT00003290 ·Status: COMPLETED ·Phase: PHASE3
-
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy
NCT04430192 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
NCT01028885 ·Status: COMPLETED ·Phase: PHASE1
-
Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
NCT02946008 ·Status: COMPLETED ·Phase: PHASE1
-
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
NCT00585962 ·Status: COMPLETED ·Phase: PHASE2
-
Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study
NCT06830408 ·Status: COMPLETED
-
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
NCT05560659 ·Status: RECRUITING ·Phase: PHASE2
-
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients
NCT02895854 ·Status: UNKNOWN ·Phase: NA
-
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer
NCT02342054 ·Status: UNKNOWN ·Phase: PHASE2
-
Hemi-Ablative Prostate Brachytherapy
NCT02632669 ·Status: COMPLETED ·Phase: NA
-
Focal Prostate Radiofrequency Ablation
NCT02294903 ·Status: UNKNOWN ·Phase: NA