Imaging with [18]F-PSMA-1007 for metastatic prostate cancer

A Phase II Study of Fluorine-18 (18F)-Labeled PSMA-1007 in Patients With Known or Suspected Metastatic Prostatic Carcinoma

This study tests if a new type of imaging scan called [18]F-PSMA-1007 can help doctors better manage treatment for people with metastatic prostate cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: AHS Cancer Control Alberta (other)
• Drugs / interventions: radiation
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05712174 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI scans in patients with known or suspected metastatic prostate cancer. It aims to assess how this imaging technique impacts patient management plans and its diagnostic accuracy compared to standard imaging methods like CT and bone scans. Participants will undergo imaging and complete questionnaires to evaluate changes in their management based on the scan results. The study is designed as a Phase II, controlled, open-label trial conducted at a single site.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with confirmed prostate cancer and specific clinical criteria indicating high risk or metastatic disease.

Not a fit: Patients with non-prostate cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer detection and enhance treatment planning for patients.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches, indicating potential for success in this study.

Eligibility criteria

Inclusion Criteria:

1. Confirmed prostate cancer by histopathology or cytology;
2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
3. Males at least 18 years of age;
4. Any of the following clinical criteria:

   * High risk localized, treatment naive prostate cancer, defined as clinical ≥T3a, Gleason score ≥8 (or grade group 4-5), or PSA \>20ng/mL. Clinical T-stage may be defined based on physical exam or standard pelvic imaging (MRI/CT).
   * High-tier intermediate risk, defined as at least two of the following: clinical T2c, Gleason score ≥7 (or Grade group 2-3) and PSA 10-20 ng/mL.
   * Biochemically recurrent prostate cancer defined as persistently elevated or rising PSA after radical prostatectomy, with a PSA value of ≥0.2ng/mL on at least two readings, or PSA with a rise of at least ≥2 ng/mL above the nadir in patients who have received definitive radiation therapy (28).
   * Metastatic disease documented on conventional imaging (CT and/or bone scan).
5. 99m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
6. Receipt of a complete \[18\]F-PSMA-1007 PET/CT or PET/MRI referral package, including baseline history information and treatment intent from the referring physician, prior to enrolment.
7. Able and willing to follow instructions and comply with the protocol;
8. Ability to provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
2. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
3. Weight exceeding the PET/CT or PET/MRI scanner limit;
4. Known allergic reaction to \[18\]F-PSMA-1007;
5. Patients who have initiated new therapy (ADT, systemic therapy, or radiation) for their prostate cancer within 4 weeks of enrollment in those with high-tier intermediate risk or high risk localized prostate cancer, or biochemically recurrent prostate cancer post-prostatectomy or definitive radiotherapy.

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Principal investigator: Stella Koumna, MD — Cross Cancer Institute, Alberta Health Services
• Study coordinator: Stella Koumna, MD

Conditions: Oncology, Prostate Cancer, PSMA, [18]F-PSMA-1007, Positron Emission Tomography