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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520255
• Other study ID #: CC-22-0204
• Status: Recruiting
• Phase: Phase 3
• Start date: July 25, 2023
• Est. completion date: December 2029

Study information

• Verified date: August 2023
• Source: University of Alberta
• Contact: Jonathan T Abele, MD
• Phone: 780-407-6907
• Email: jabele[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 18F-PSMA-1007
18F-PSMA-1007 intravenous injection

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - immediate	The participant will be screened for adverse effects immediately post-injection	Immediately after tracer injection
Primary	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
Primary	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
Primary	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