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

NCT05520255 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2800

Last updated 2025-09-23

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

18F-PSMA-1007

18F-PSMA-1007 intravenous injection

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520255 on ClinicalTrials.gov