18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

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

1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
2. Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
3. Adult patients 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 mcg/L, OR minimum clinical T-stage T2c
4. Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)

The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:

1. The participant will be screened for adverse effects immediately post-injection
2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
3. The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)

The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:

1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
2. The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
3. Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021)
4. Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 18F-PSMA-1007

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jonathan T Abele, MD; Phone Number: 780-407-6907; Email: jabele@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Recruiting
      • University of Alberta
      • Contact: Jonathan Abele, MD; Phone Number: 780-407-6907; Email: jabele@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
2. Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
3. Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
4. Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)

Exclusion Criteria:

1. Unable to obtain consent
2. Weight > 225 kg (weight limit of PET/CT scanners)
3. Unable to lie flat for 30 minutes to complete the PET/CT imaging session
4. Lack of intravenous access
5. History of allergic reaction to 18F-PSMA-1007
6. Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
7. Less than 18 years old

NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation

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; 18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose	Drug: 18F-PSMA-1007; 18F-PSMA-1007 intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - immediate	The participant will be screened for adverse effects immediately post-injection	Immediately after tracer injection
Safety - post scan	The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection).	2.5 hours after tracer injection
Safety - delayed	The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection)	1-7 days after tracer injection
Non-specific bone lesion assessment (NSBLs)	SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection	1 year after tracer injection

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: August 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-22-0204

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