PSMA-PET/CT Registry

NCT05709535 | Terminated

• 1 other identifier: PSMA-PET-1007
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective registry study to evaluate the diagnostic utility of \[18F\]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites, utilizing a new Positron Emission Tomography (PET) tracer, [18F]-PSMA-1007 (PSMA-PET/CT).

  The proportion of PSMA-PET/CT imaging with positive findings (whether at local, regional, or distant sites).

  1 year

Secondary Outcomes (2)

• To assess the predictive value of PSMA-PET/CT imaging on patient outcomes (e.g., radiographic/PSA progression free survival).

  1 year

• To assess the predictive value of PSMA-PET/CT imaging on patient outcomes (e.g., PSA response).

  1 year

Study Arms (1)

Experimental: [18F]PSMA-1007 Injection

A single intravenous dose of 3 - 4 MBq/kg (up to a maximum of 400 MBq) of \[18F\]PSMA-1007 Injection will be administered followed by PET/CT imaging.

Diagnostic Test: [18F]-PSMA-1007

Interventions

[18F]-PSMA-1007 DIAGNOSTIC_TEST

\[18F\]PSMA-1007 is a diagnostic radiopharmaceutical for Positron Emission Tomography (PET) scan. The intervention involves single intravenous administration of \[18F\]PSMA-1007 for PET scan.

Experimental: [18F]PSMA-1007 Injection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High-Risk, Biochemically Relapsed, and Advanced Prostate Cancer

You may qualify if:

• Study participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age greater than or equal to 18 years.
• Subjects with histological diagnosis of prostate cancer.
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values \>0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values \>0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
• Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level \>2 ng/mL above the nadir after radiation therapy OR
• Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
• Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
• Subjects with high-risk prostate cancer, defined as T3a, Gleason ≥8, or PSA ≥20, and "very high risk" as T3b or T4 disease.
• Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 90 days after the last dose of study intervention.

You may not qualify if:

• Unable to lie supine for the duration of imaging.
• Unable to provide written consent.
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm).
• Lack of IV access.
• History of allergic reaction to \[18F\]-PSMA-1007.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Steven Yip, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 2, 2023
• Study Start: July 11, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)