Clinical Trials Logo

Clinical Trial Summary

This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease. A threshold rate of 15% detection will be considered clinically significant. SEONDARY OBJECTIVE: I. Assessment of safety. EXPLORATORY OBJECTIVES: I. Determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups. II. Correlate PET MRI findings with surgical specimens for those men who undergo surgical treatment (including assessment of pathological stage). III. Define whether gene expression of PSMA (FOLH1) as defined on the Decipher messenger ribonucleic acid (mRNA) expression platform relates to signal intensity on PSMA scan. IV. Determine whether Decipher genomic classifier scores, luminal / basal scores or androgen receptor activity scores relate to signal intensity on PSMA scans. OUTLINE: Patients receive rhPSMA-7.3 intravenously (IV) then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05852041
Study type Interventional
Source Northwestern University
Contact Nikki Hubbard
Phone 312-694-9001
Email nikki.hubbard@northwestern.edu
Status Recruiting
Phase Early Phase 1
Start date August 7, 2023
Completion date June 7, 2035

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03796767 - Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer Phase 2
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT05735223 - A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence N/A
Recruiting NCT04175431 - Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study Phase 2
Completed NCT05197257 - 68Ga-PSMA-11 PET in Patients With Prostate Cancer Phase 3
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Terminated NCT02491411 - Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel N/A
Active, not recruiting NCT02254746 - A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer N/A
Active, not recruiting NCT05496959 - 177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study Phase 2
Completed NCT02940262 - Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy Phase 3
Recruiting NCT04391556 - Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma Phase 2
Enrolling by invitation NCT03503643 - Hemi-Gland Cryoablation for Prostate Cancer at UCLA
Recruiting NCT05832086 - Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes Phase 2
Suspended NCT05064111 - Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
Not yet recruiting NCT04031378 - Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer Phase 2
Recruiting NCT02600156 - Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors N/A
Recruiting NCT05726292 - A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer Phase 2
Recruiting NCT04423211 - Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging Phase 3
Terminated NCT03718338 - Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Patients With Prostate Adenocarcinoma
Terminated NCT02564549 - MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca N/A