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The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA | Drug | All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer | Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2:
| Up to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of 64-CuSAR-bisPSMA | Incidence and severity of TEAEs and SAEs following the administration of 64CuSARbisPSMA | Up to 52 Weeks |
| To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT |
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Inclusion Criteria:
At least 18 years of age.
Signed informed consent.
Life expectancy ≥ 6 months as determined by the Investigator.
Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
PSA level after definitive therapy:
Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
An Eastern Cooperative Oncology performance status of 0-2.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine | Irvine | California | 92697 | United States | ||
| Comprehensive Urology Medical Group |
Concerns related to confidentiality.
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Participant-level PPV, defined as the proportion of participants with a TP scan out of all participants with a true or false positive scan.
| Up to 52 Weeks |
| To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT | Participant-level DR, defined as the proportion of participants with a positive scan out of all participants. | Up to 52 Weeks |
| To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline | Detection Rate in participants with a negative or equivocal conventional imaging at baseline. | Up to 52 Weeks |
| To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT | Positive Predictive Value (participant- and region-level) assessed in subgroups based on the type of evidence and with/without histopathology. | Up to 52 Weeks |
| To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings | Inter-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers. | Up to 52 Weeks |
| To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings | Intra-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers. | Up to 52 Weeks |
| To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline | Positive Predictive Values (participant and region level) in participants with a negative or equivocal conventional imaging at baseline. | Up to 52 Weeks |
| To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT | Correct Detection Rate assessed in subgroups based on the type of evidence and with/without histopathology. | Up to 52 Weeks |
| Los Angeles |
| California |
| 90048 |
| United States |
| Alarcon Urology Center | Montebello | California | 90640 | United States |
| Biogenix Molecular | Miami | Florida | 33165 | United States |
| Endeavor Health- Glenbrook Hospital | Glenview | Illinois | 60201 | United States |
| Indiana University Health-IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| XCancer Research Network / LCMC Health EJGH | Metairie | Louisiana | 700006 | United States |
| M. Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| St. Louis University | St Louis | Missouri | 63103 | United States |
| XCancer | Omaha | Nebraska | 68130 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15260 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| The Urology Place | San Antonio | Texas | 78240 | United States |
| Summit Urology | Murray | Utah | 84107 | United States |
| Intermountain Medical Center | Salt Lake City | Utah | 84111 | United States |
| St. Vincent's Hospital, Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Sydney Adventist Hospital | Wahroonga | New South Wales | 2076 | Australia |
| Westmead Private Hosptial | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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