18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer

Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: 18F-PSMA-1007

Detailed Description

A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:

1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) > 0.2 µg/L
2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months
3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.

All patients will have a comparison conventional imaging study performed within 10 days of the investigational PET/CT scan. The conventional imaging study will include a 99mTc -MDP bone scan including whole body planar imaging (top of skull to toes) as well as SPECT/CT imaging of the trunk (including clavicles to pelvis). In the absence of contraindications (renal failure with eGFR < 40 mL/min/1.73m2 or history of IV contrast allergy), all scans will include an IV-contrast enhanced CT scan of the chest, abdomen, and pelvis. In the presence of contraindications to IV contrast, a non-IV contrast enhanced CT scan of the chest, abdomen, and pelvis will be performed.

The biodistribution of 18F-PSMA-1007 produced by the Edmonton PET Centre will be evaluated in 2 ways:

• by comparing the biodistribution of tracer on the scans to an expected normal distribution.

• for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:

  • A - lesion identified on the investigational imaging study but not on the conventional imaging study
  • B - matching lesions on both the investigational and conventional imaging studies
  • C - lesion identified on the conventional imaging study but not on the investigational imaging study

The clinical efficacy of 18F-PSMA-1007 will be evaluated as follows:

• a follow-up questionnaire will be sent to referring clinicians 6 months after the scan to determine if the scans were of perceived clinical benefit.

The safety of 18F-PSMA-1007 produced by Edmonton PET Centre will be evaluated in 3 ways:

• the patients will be screened for adverse effects immediately post-injection as well as after the scan (approximately 2.5 hours after injection)
• the patients will be provided an information sheet and contact information for self-reporting of delayed adverse events (1-7 days post injection)
• a 6 month follow-up questionnaire will be sent to referring clinicians to determine if there were any perceived adverse events related to the injection

The diagnostic accuracy of 18F-PSMA-1007PET/CT produced by Edmonton PET Centre will be evaluated as follows:

• All lesions categorized as "A", "B", or "C" will be compared with a reference standard to determine sensitivity and specificity on both a per lesion and per patient level
• The reference standard will be defined a minimum of 1 year after completion of both scans based on available clinical data
• Lesional histopathology results will be used as the reference standard when available
• When pathology is unavailable, criteria for determining lesional positivity for metastatic disease will be based on recently published methodology (Lawhn-Heath et al., AJR 2019;213:1-8)
• If lesion the criteria for determining lesion positivity are not met, the lesion will be considered unevaluable and will be excluded from assessment of accuracy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) > 0.2 µg/L
2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months
3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.

Exclusion Criteria:

1. Unable to obtain consent
2. Weight >225 kg (weight limitation of PET/CT scanner)
3. Unable to lie flat for 30 minutes to complete the PET-CT imaging session
4. Lack of intravenous access
5. Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
6. History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-PSMA-1007 PET/CT scan; Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan	Diagnostic test: 18F-PSMA-1007; 18f-PSMA-1007 PET/CT scan; Other Names: [18F]PSMA-1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - immediate	Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site	Immediately (within 15 minutes) after 18F-PSMA-1007 injection
Safety - post scan	Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site	2.5 hours after 18F-PSMA-1007 injection
Safety - delayed	Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection	6 months after 18F-PSMA-1007 injection
Biodistribution	Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease	Within 5 days of scan
Diagnostic Accuracy	Lesion by lesion comparison to conventional imaging (bone scan and CT scan) performed 2-10 days after the 18F-PSMA-1007 PET/CT scan. Reference standard based on lesion pathology (if available) or 1 year clinical/imaging following (using criteria published by Lawhn-Heath et al., AJR 2019;213:1-8.	1 year after 18F-PSMA-1007 PET/CT scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy	Questionnaire completed by referring physicians evaluating the perceived clinical effect of the 18F-PSMA-1007 PET/CT on patient management	6 months after the 18F-PSMA-1007 PET/CT scan

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CC-20-0281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No