[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07285057":3,"trial-entities:NCT07285057":134,"trial-summary:NCT07285057":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":50,"secondary_outcomes":55,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":100,"locations":103,"central_contacts":124,"overall_officials":130,"references":132,"see_also_links":133},"NCT07285057","STUDY-25-00518","Diagnostic Utility of rhPSMA-7.3 (18F) PET\u002FCT in Men With Prostate Cancer on Active Surveillance","Diagnostic Utility of rhPSMA-7.3 (18F) PET \u002FCT Imaging in Patients With Prostate Cancer on Active Surveillance","RECRUITING","2027-05-01","2026-02","2026-02-23","2026-02-10","Icahn School of Medicine at Mount Sinai","OTHER",true,"This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET\u002FCT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET\u002FCT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET\u002FCT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET\u002FCT, MRI, and pathology, and evaluate the predictive value of PET\u002FCT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.","This investigator-initiated, single-center, prospective study aims to evaluate the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET\u002FCT (flotufolastat F18, marketed as POSLUMA®) in detecting clinically significant prostate cancer (csPCa) among men on active surveillance for low-risk or favorable intermediate-risk prostate cancer.\n\nBackground and Rationale: Active surveillance (AS) is the preferred management strategy for carefully selected men with low-risk and favorable intermediate-risk prostate cancer, balancing the avoidance of overtreatment against the need to identify disease progression early. Current surveillance strategies rely on serial PSA monitoring, digital rectal examination, mpMRI, and confirmatory biopsies. However, mpMRI can miss or underestimate clinically significant lesions, particularly those in the anterior or transitional zones. Prostate-specific membrane antigen (PSMA) is highly expressed in prostate cancer cells and can be visualized using PET\u002FCT imaging with radiolabeled PSMA ligands. The next-generation tracer rhPSMA-7.3 (¹⁸F), or flotufolastat F18, has demonstrated improved image resolution, favorable kinetics, and low urinary excretion compared to earlier PSMA ligands. Incorporating PSMA PET\u002FCT into the active surveillance pathway may identify occult or higher-grade disease not detected by MRI, improving risk stratification and treatment decision-making.\n\nStudy Objectives: The primary objective of the study is to determine whether the addition of rhPSMA-7.3 (¹⁸F) PET\u002FCT to standard mpMRI improves detection of clinically significant prostate cancer (ISUP Grade Group ≥2) in men on active surveillance.\n\nSecondary objectives include: Comparing lesion-level concordance between PET\u002FCT, mpMRI, and histopathology. Evaluating the predictive value of PET SUVmax for detecting clinically significant disease. Assessing diagnostic performance metrics (sensitivity, specificity, PPV, NPV) for PET\u002FCT versus MRI. Quantifying the proportion of patients reclassified (i.e., upgraded or transitioned from AS to definitive treatment) based on PET\u002FCT findings.\n\nExploratory endpoints include: Association between PET quantitative parameters (SUVmax, lesion volume) and PSA density. Characterization of PET-only lesions not visualized on MRI. Correlation of PET\u002FCT findings with adverse pathological features (ECE, SVI, cribriform\u002Fintraductal carcinoma) at biopsy or surgery. Evaluation of lesion-level changes in SUVmax and volume in patients who undergo repeat PET\u002FCT.\n\nStudy Design: This is a prospective, single-arm diagnostic utility study. Approximately 120 participants with histologically confirmed low-risk or favorable intermediate-risk prostate cancer managed with active surveillance will be enrolled at Mount Sinai Hospital. All participants will undergo both mpMRI and rhPSMA-7.3 (¹⁸F) PET\u002FCT prior to confirmatory biopsy. Imaging data will be reviewed by genitourinary radiologists and nuclear medicine physicians blinded to each other's findings. Lesions will be recorded according to standardized templates (e.g., PIRADS 2.1 for MRI and SUV-based mapping for PET\u002FCT). Targeted biopsies will include MRI-positive, PET-positive, and fusion (concordant) targets, as well as systematic cores as per institutional protocol. Histopathology will serve as the reference standard for correlation. The study involves one PET\u002FCT visit, one confirmatory biopsy, and up to three follow-up visits within 12 months.\n\nRisks and Benefits: Risks include exposure to low-dose radiation comparable to standard diagnostic imaging, and expected biopsy-related discomfort such as pain, bleeding, infection, or transient urinary symptoms. Rare allergic reactions to flotufolastat F18 and mild emotional stress associated with imaging or awaiting results are possible but uncommon. There may be no direct benefit to participants. However, rhPSMA-7.3 (¹⁸F) PET\u002FCT may help identify previously undetected higher-grade disease, leading to earlier or more appropriate treatment. The findings could improve future management of men on active surveillance.\n\nStatistical Considerations: Diagnostic accuracy metrics will be analyzed at both lesion and patient levels using confirmatory biopsy as the gold standard. ROC analysis will determine SUVmax thresholds for predicting clinically significant disease. Concordance between PET and MRI findings will be evaluated with Cohen's kappa and McNemar's test. Sample size (n=120) is based on expected detection differences between PET\u002FCT and MRI with 80% power and alpha=0.05.\n\nStudy Oversight: This study is conducted under the oversight of the Mount Sinai Program for the Protection of Human Subjects (PPHS) and complies with FDA regulations for IND-exempt studies involving FDA-approved radiopharmaceuticals (21 CFR 312.2(b)(1)). The study is jointly funded by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics. Mount Sinai is the study sponsor and holds regulatory responsibility. Blue Earth Diagnostics provides the imaging agent flotufolastat F18 (POSLUMA®), technical support, and partial financial support. Data management and analysis will be conducted internally at Mount Sinai. No external contract research organization (CRO) or vendor (e.g., Parexel) will manage study data.\n\nExpected Duration: Enrollment start: November 2025 Primary completion: May 2027 (final confirmatory biopsy) Study completion: November 2027 (data lock and analysis)\n\nPotential Impact: This study may validate the clinical role of rhPSMA-7.3 (¹⁸F) PET\u002FCT in improving detection of clinically significant prostate cancer during active surveillance. The results may support integration of PSMA-targeted PET imaging into future diagnostic pathways, minimizing unnecessary biopsies and improving individualized management.",[19,20,21],"Prostatic Neoplasms","Prostate Cancer","Prostate Adenocarcinoma",[23,24,25,26,27,28],"Prostate cancer","Prostatic neoplasms","Active surveillance","PSMA PET\u002FCT","rhPSMA-7.3","Prostate biopsy","INTERVENTIONAL","DIAGNOSTIC",[32],"PHASE2",{"count":34,"type":35},120,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"RADIATION","rhPSMA-7.3 (18F) PET\u002FCT Imaging (Flotufolastat F18, POSLUMA®)","Participants will undergo a single rhPSMA-7.3 (¹⁸F) PET\u002FCT scan using flotufolastat F18 (POSLUMA®), an FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET\u002FCT image acquisition. The scan will be performed according to institutional imaging protocols, approximately 50-70 minutes post-injection.",[42],"rhPSMA-7.3 (18F) PET\u002FCT Imaging",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Flotufolastat F18","An FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET\u002FCT image acquisition.",[42],[49],"POSLUMA®",[51],{"measure":52,"description":53,"timeFrame":54},"Proportion of participants with Grade Group ≥ 2","Detection rate measured by the proportion of participants with clinically significant prostate cancer (csPCa) (Grade Group ≥2) using rhPSMA-7.3 (¹⁸F) PET\u002FCT compared to standard mpMRI confirmed on targeted or systematic biopsy\n\nClinically significant prostate cancer is defined as Gleason Grade Group ≥ 2 (Gleason score ≥ 3+4 Predominantly well-formed glands with a lesser component of poorly-formed\u002Ffused\u002Fcribriform glands) based on histopathologic evaluation of biopsy cores obtained after PET\u002FCT imaging.","Up to 3 months after PET\u002FCT imaging",[56,60,64,68,71,74,77,80],{"measure":57,"description":58,"timeFrame":59},"Incremental detection rate of csPCa by PET\u002FCT over MRI","Proportion of participants in whom PET\u002FCT leads to biopsy-confirmed csPCa (Grade Group ≥2) from a PET-positive \u002F MRI-negative target measured by number of participants with csPCa detected on PET-positive, MRI-negative lesion from all participants who complete both imaging modalities and biopsy.","up to 6 months",{"measure":61,"description":62,"timeFrame":63},"Lesion-level concordance between rhPSMA-7.3 (¹⁸F) PET\u002FCT, multiparametric MRI, and histopathology","Concordance (Yes\u002FNo) per lesion for location (lobe\u002Fzone\u002Fsegment) and significance (csPCa yes\u002Fno on biopsy).","Up to 6 months following enrollment (from baseline imaging to confirmatory biopsy)",{"measure":65,"description":66,"timeFrame":67},"Predictive value of PET SUVmax for detecting clinically significant disease","Comparing lesion-level concordance between PET\u002FCT, mpMRI, and histopathology. Evaluating the predictive value of PET SUVmax for detecting clinically significant disease.","Baseline to 6 months",{"measure":69,"description":70,"timeFrame":67},"Sensitivity","Sensitivity is defined as the probability of a positive PET\u002FCT who actually have clinically significant disease.",{"measure":72,"description":73,"timeFrame":67},"Specificity","Specificity is defined as the proportion of a true negatives on PET\u002FCT who do not have clinically significant disease.",{"measure":75,"description":76,"timeFrame":67},"Positive Predictive Value (PPV)","PPV is defined as the probability that a positive PET\u002FCT is actually positive.",{"measure":78,"description":79,"timeFrame":67},"Negative Predictive Value (NPV)","NPV is defined as the probability that a negative PET\u002FCT is actually negative.",{"measure":81,"description":82,"timeFrame":67},"Number of participants that were reclassified","Quantifying the proportion of patients reclassified (i.e., upgraded or transitioned from Active Surveillance (AS) to definitive treatment) based on PET\u002FCT findings.","MALE","18 Years",null,false,{"inclusion":88,"exclusion":94,"raw_text":99},[89,90,91,92,93],"Male participants aged ≥18 years.","Histologically confirmed diagnosis of prostate adenocarcinoma.","Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \\\u003C10 ng\u002FmL, cT1-T2a Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng\u002FmL, cT2b-c Currently managed with active surveillance.","Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT imaging, mpMRI, and confirmatory prostate biopsy.","Able to provide written informed consent.",[95,96,97,98],"A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer.","Contraindication to 3-T mpMRI.","Significant intercurrent morbidity\\*\\* limiting compliance with study protocols.","History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.","Inclusion Criteria:\n\n* Male participants aged ≥18 years.\n* Histologically confirmed diagnosis of prostate adenocarcinoma.\n* Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \\\u003C10 ng\u002FmL, cT1-T2a Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng\u002FmL, cT2b-c Currently managed with active surveillance.\n* Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT imaging, mpMRI, and confirmatory prostate biopsy.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer.\n* Contraindication to 3-T mpMRI.\n* Significant intercurrent morbidity\\*\\* limiting compliance with study protocols.\n\n  \\*\\* Significant intercurrent morbidity refers to a substantial medical condition or complication that arises during a study or treatment, which is severe enough to impact the patient's participation, treatment outcomes, or overall prognosis. These conditions may be unrelated to the primary disease but can influence clinical decision-making, treatment efficacy, and patient safety. Examples include major infections, cardiovascular events, organ failure, or significant worsening of pre-existing comorbidities (https:\u002F\u002Fdoi.org\u002F10.1016\u002FS1053-4296(03)00031-6).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":105,"status":8,"city":106,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":121},"Mount Sinai Hospital \u002F Icahn School of Medicine at Mount Sinai","New York","10029","United States",[110,115,118],{"name":111,"role":112,"phone":113,"email":114},"Neeraja Tillu, MBBS, MS, MCh","CONTACT","646-799-1870","neeraja.tillu@mountsinai.org",{"name":116,"role":112,"email":117},"Monali Fatterpekar","Monali.Fatterpekar@mountsinai.org",{"name":119,"role":120},"Ashutosh Tewari","PRINCIPAL_INVESTIGATOR",{"lat":122,"lon":123},40.71427,-74.00597,[125,127],{"name":126,"role":112,"phone":113,"email":114},"Neeraja Tillu, MBBS, MS, MCh.",{"name":128,"role":112,"email":129},"Monali Fatterpekar, PhD","monali.fatterpekar@mountsinai.org",[131],{"name":119,"affiliation":13,"role":120},[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[136],"Prostate Carcinoma",[138],"KLK3 Gene",{"nct_id":4,"found":15,"summary":140,"prompt_version":149},{"design":141,"status":142,"heading":6,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is a single-center study that aims to enroll 120 participants. It is an interventional study, meaning participants will receive a specific intervention.","completed","This study is looking at how well a special type of scan, called rhPSMA-7.3 (18F) PET\u002FCT, helps doctors find prostate cancer that might be more serious. This scan uses a substance called flotufolastat F18 (also known as POSLUMA®), which is approved by the FDA. You might be able to join if you are a man, 18 or older, with prostate cancer that has been confirmed by a biopsy and is considered low-risk or favorable intermediate-risk. You should also be currently managed with active surveillance, meaning your doctors are watching your cancer closely without immediate treatment. The main goal is to see if adding this PET\u002FCT scan to standard MRI (magnetic resonance imaging) helps detect more significant prostate cancer. The study is currently unclear on its recruitment status.","Participants will be followed for up to 3 months after their PET\u002FCT imaging to assess the proportion of participants with Grade Group ≥ 2.",127,"Participants will have one rhPSMA-7.3 (18F) PET\u002FCT scan after receiving an intravenous injection of flotufolastat F18. They will also undergo an mpMRI and a confirmatory prostate biopsy.","Not stated in the trial record.",[45],"v2"]