A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer

NCT05712174 | Terminated Phase 2 DMC

• 1 other identifier: IIT-0030
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

A \[18\]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors. The purpose of this study is to: 1) assess the clinical impact of a \[18\]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a \[18\]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of \[18\]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.

Conditions

Oncology; Prostate Cancer

Keywords

PSMA; [18]F-PSMA-1007; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans

  There is sparsity of evidence regarding the impact of the results of \[18\]F-PSMA-1007 PET/CT or PET/MRI on patient management. With this analysis we will study whether the treatment plan is modified with the findings of the \[18\]F-PSMA-1007 PET/CT or PET/MRI, by asking the referring physician to complete a questionnaire on paper or electronically (via REDCap). Questions will include the patient's clinical TNM stage, treatment intent (curative vs palliative), planned treatment modalities, and clinical confidence in their treatment plan, both before and after \[18\]F-PSMA-1007 imaging.

  Prior to and within 30 days following [18]F-PSMA-1007 PET/CT or PET/MRI

Secondary Outcomes (5)

• To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (CT chest, abdomen, pelvis)

  Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI

• To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (bone scan)

  Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI

• The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (PSA value)

  Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI

• The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (Gleason score)

  Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI

• To evaluate the safety of [18]F-PSMA-1007 PET/CT or PET/MRI imaging

  Up to 24 hours after [18]F-PSMA-1007 administration

Study Arms (1)

[18]F-PSMA-1007 PET/CT or PET/MRI

EXPERIMENTAL

All participants will undergo a single \[18\]F-PSMA-1007 PET/CT or PET/MRI scan. Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.

Drug: [18]F-PSMA-1007

Interventions

[18]F-PSMA-1007 DRUG

\[18\]F-PSMA-1007 is a diagnostic radiopharmaceutical for use with PET/CT or PET/MRI scanning to diagnose prostate cancer.

[18]F-PSMA-1007 PET/CT or PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed prostate cancer by histopathology or cytology;
• Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
• Males at least 18 years of age;
• 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).
• m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
• 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.
• Able and willing to follow instructions and comply with the protocol;
• Ability to provide written informed consent prior to participation in the study.

You may not qualify if:

• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
• Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
• Weight exceeding the PET/CT or PET/MRI scanner limit;
• Known allergic reaction to \[18\]F-PSMA-1007;
• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Stella Koumna, MD

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 3, 2023
• Study Start: September 14, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)