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Trial Title:
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
NCT ID:
NCT05520255
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Two-centre prospective cohort phase III study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-PSMA-1007
Description:
18F-PSMA-1007 intravenous injection
Arm group label:
18F-PSMA-1007
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
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Zip:
T6G 2R3
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jonathan Abele, MD
Phone:
780-407-6907
Email:
jabele@ualberta.ca
Start date:
July 25, 2023
Completion date:
December 2029
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520255