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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 (HIFU) - 18F-PSMA | Experimental | 10 mCi ±20% F18-PSMA injection |
|
| ARM 2 (RP) - 18F-PSMA | Experimental | 10 mCi ±20% F18-PSMA injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PSMA | Drug | Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months following standard HIFU therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After study completion, an average of 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro D'Agnolo, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37682613 | Derived | Basso Dias A, Ghai S, Ortega C, Mirshahvalad SA, Perlis N, Berlin A, Avery L, Veit-Haibach P, van der Kwast T, Metser U. Impact of 18F-DCFPyL PET/MRI in Selecting Men With Low-/Intermediate-Risk Prostate Cancer for Focal Ablative Therapies. Clin Nucl Med. 2023 Oct 1;48(10):e462-e467. doi: 10.1097/RLU.0000000000004819. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM 1 (HIFU) - 18F-PSMA | 10 mCi ±20% F18-PSMA injection 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 |
| FG001 | ARM 2 (RP) - 18F-PSMA | 10 mCi ±20% F18-PSMA injection 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM 1 (HIFU) - 18F-PSMA | 10 mCi ±20% F18-PSMA injection 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 |
| BG001 | ARM 2 (RP) - 18F-PSMA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed is 32 and not 29, because some participants switched over to the RP arm after already completing study intervention (imaging). | Posted | Number | biopsy-proven cancerous zones | At time of pre-HIFU biopsy | biopsy-zones | biopsy-zones |
|
Through study completion, an average of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM 1 (HIFU) - 18F-PSMA | 10 mCi ±20% F18-PSMA injection 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SOB | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute DVT (Deep Vein Thrombosis) Right Femoral Vein | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Sarmiento | Cedars-Sinai Medical Center | 310-423-4295 | Laura.sarmiento@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2023 | Jan 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)
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|
| Secondary Endpoint (Prostatectomy): | Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up. | 6 months following standard HIFU therapy |
10 mCi ±20% F18-PSMA injection 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 mCi ±20% F18-PSMA injection 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 Difference between sensitivities to identify prostate lesions. |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery |
|
|
|
| Secondary | 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. | Negative for any cancer in treated area, including high and low grade cancer 17/22 (77.3%) Negative for high-grade cancer in treated area 18/22 (81.8%) There were 4/22 patients who had high grade cancer in the treated area, and one patient who had low grade cancer in the treated area. Hence, 18/22 were negative for high grade cancer in the treated area while 17/22 were negative for both high grade or low grade cancer. | Posted | Count of Participants | Participants | 6 months following standard HIFU therapy |
|
|
|
| Secondary | Secondary Endpoint (Prostatectomy): | Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up. | Not Posted | 6 months following standard HIFU therapy | Participants |
| Other Pre-specified | 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. | Not Posted | After study completion, an average of 6 months | Participants |
| 0 |
| 24 |
| 1 |
| 24 |
| 3 |
| 24 |
| EG001 | ARM 2 (RP) - 18F-PSMA | 10 mCi ±20% F18-PSMA injection 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 | 0 | 32 | 4 | 32 | 5 | 32 |
| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sigmoid Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Wall Fluid Collection | Hepatobiliary disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Intractable Back Pain | General disorders | Systematic Assessment |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Blood Loss Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Septecemia | Infections and infestations | Systematic Assessment |
|
| Syncope Post-Chemo | General disorders | Systematic Assessment |
|
| Fever Post-Chemo | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Increased ALT (Alanine aminotransferase) | Hepatobiliary disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Perineal Pain | General disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Right Groin Pain | General disorders | Systematic Assessment |
|
| Hyponatremia | Nervous system disorders | Systematic Assessment |
|
| Bladder Discomfort | Renal and urinary disorders | Systematic Assessment |
|
| Burning Urination for One Week | Renal and urinary disorders | Systematic Assessment |
|
| Facial Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Osteoarthritis of Left Knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Effusion of Left Knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tongue Swelling - Allergic Reaction to Contrast | General disorders | Systematic Assessment |
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |