A Phase 2 interventional study of 18F-PSMA in Prostatic Neoplasms, Genital Neoplasms, Male and Urogenital Neoplasms, sponsored by Alessandro D'Agnolo. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Alessandro D'Agnolo · Phase 2, Interventional, and Other
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.
Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.
Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Alessandro D'Agnolo as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mCi ±20% F18-PSMA injection
Drug: 18F-PSMA
10 mCi ±20% F18-PSMA injection
Drug: 18F-PSMA
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer
Also known as: 18F-DCFPyL Injection
Primary Endpoint (HIFU): Identification of New Cancers
The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
Time frame: At time of pre-HIFU biopsy
Primary Endpoint (HIFU):
The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.
Time frame: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery
Secondary Endpoint (HIFU):
Negative biopsy rate on systematic and targeted biopsy 6 months following HIFU therapy. Data presented are from both systematic + targeted biopsy as a single unit. For example, a positive biopsy from a given area of the prostate could have come from either systematic or targeted cores.
Time frame: 6 months following standard HIFU therapy
Secondary Endpoint (Prostatectomy):
Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.
Time frame: 6 months following standard HIFU therapy
Exploratory Endpoint:
RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.
Time frame: After study completion, an average of 6 months
The trial opened to accrual on 04/06/2021 with first subject enrolled on study 04/06/2021. Recruitment occurred at Cedars-Sinai Medical Center.
| Milestone | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA |
|---|---|---|
| Started | 29 | 33 |
| Completed | 24 | 32 |
| Not completed | 5 | 1 |
The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
| biopsy-proven cancerous zones | ARM 1 (HIFU) - 18F-PSMA |
|---|---|
| Gleason 6+ | 85 |
| Gleason 7+ | 49 |
The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.
| Participants | Arm 1 Focal High-Intensity Focused Ultrasound (HIFU) |
|---|---|
| Primary Endpoint (HIFU): | 8 |
Negative biopsy rate on systematic and targeted biopsy 6 months following HIFU therapy. Data presented are from both systematic + targeted biopsy as a single unit. For example, a positive biopsy from a given area of the prostate could have come from either systematic or targeted cores.
| Participants | ARM 1 (HIFU) - 18F-PSMA |
|---|---|
| Negative for any cancer in treated area, including high and low grade cancer | 17 |
| Negative for high-grade cancer in treated area | 18 |
Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.
No measurements were reported for this outcome.
RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.
Results for this outcome have not been posted.
Collected over Through study completion, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARM 1 (HIFU) - 18F-PSMA | 0/24 (0%) | 1/24 (4.2%) | 3/24 (12.5%) |
| ARM 2 (RP) - 18F-PSMA | 0/32 (0%) | 4/32 (12.5%) | 5/32 (15.6%) |
| Event | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA |
|---|---|---|
| Intractable Back PainGeneral disorders | 1/24 | 0/32 |
| SOBRespiratory, thoracic and mediastinal disorders | 0/24 | 1/32 |
| HematomaBlood and lymphatic system disorders | 0/24 | 1/32 |
| Sigmoid DiverticulitisGastrointestinal disorders | 0/24 | 1/32 |
| Abdominal Wall Fluid CollectionHepatobiliary disorders | 0/24 | 1/32 |
| FeverGeneral disorders | 0/24 | 1/32 |
| HematuriaRenal and urinary disorders | 0/24 | 1/32 |
| Urinary RetentionRenal and urinary disorders | 0/24 | 1/32 |
| Event | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 1/24 | 2/32 |
| Urinary RetentionRenal and urinary disorders | 1/24 | 1/32 |
| ConstipationGastrointestinal disorders | 1/24 | 0/32 |
| Right Groin PainGeneral disorders | 1/24 | 0/32 |
| HyponatremiaNervous system disorders | 1/24 | 0/32 |
| Bladder DiscomfortRenal and urinary disorders | 1/24 | 0/32 |
| Burning Urination for One WeekRenal and urinary disorders | 1/24 | 0/32 |
| Facial RashSkin and subcutaneous tissue disorders | 1/24 | 0/32 |
| Osteoarthritis of Left KneeMusculoskeletal and connective tissue disorders | 1/24 | 0/32 |
| Effusion of Left KneeMusculoskeletal and connective tissue disorders | 1/24 | 0/32 |
| Age, Categorical(Participants) | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 17 | 27 |
| >=65 years | 14 | 15 | 29 |
| Sex: Female, Male(Participants) | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 24 | 32 | 56 |
| Ethnicity (NIH/OMB)(Participants) | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 22 | 28 | 50 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 7 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 15 | 23 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | ARM 1 (HIFU) - 18F-PSMA | ARM 2 (RP) - 18F-PSMA | Total |
|---|---|---|---|
| United States | 24 | 32 | 56 |
PDFs hosted by the registry, ClinicalTrials.gov.
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