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

NCT05520255 | Recruiting Phase 3

• 1 other identifier: CC-22-0204
• Study Type: interventional
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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. 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)
5. 5.The participant will be screened for adverse effects immediately post-injection
6. 6.The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
7. 7.The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)
8. 8.All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax \> 2.5 but no corresponding lesion on CT) will be recorded
9. 9.The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
10. 10.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)
11. 11.Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

18F-PSMA-1007

EXPERIMENTAL

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

Drug: 18F-PSMA-1007

Interventions

18F-PSMA-1007 DRUG

18F-PSMA-1007 intravenous injection

18F-PSMA-1007

Eligibility Criteria

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

You may qualify if:

• 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
• 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
• 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
• 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)

You may not qualify if:

• Unable to obtain consent
• Weight \> 225 kg (weight limit of PET/CT scanners)
• Unable to lie flat for 30 minutes to complete the PET/CT imaging session
• Lack of intravenous access
• History of allergic reaction to 18F-PSMA-1007
• Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
• Less than 18 years old
• NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

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

Central Study Contacts

Jonathan T Abele, MD

CONTACT

780-407-6907; jabele@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-centre prospective cohort phase III study

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: July 25, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)