Evaluation of Prostate-Specific Membrane Antigen (68Ga) PET/CT as a tool to guide treatment choice in patients with high risk prostate cancer

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Prostate Cancer

• Registration Number: ISRCTN56584901
• Lead Sponsor: Public Health Scotland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-13
• Study Completion: 2022-04-30
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

Current participant inclusion criteria as of 09/09/2021:
1. High-risk prostate cancer with no detectable distant metastasis using standard of care imaging (MRI prostate/pelvis, isotope bone scan, CT, non-PSMA PET/CT) undergoing radical prostatectomy and pelvic lymph node dissection
2. 68Ga-PSMA PET/CT done as part of the staging investigation
3. Histologically proven prostate cancer
4. No prior prostate cancer treatment including androgen deprivation therapy
5. Male aged =18 years
6. Considered suitable candidate for radical surgery for prostate cancer
7. Willingness to comply with scheduled visits

Previous participant inclusion criteria:
1. High risk prostate cancer with no detectable metastasis using standard of care imaging (MRI prostate/pelvis, isotope bone scan, CT, non-PSMA PET/CT) undergoing radical prostatectomy and pelvic lymph node dissection
2. Histologically proven prostate cancer
3. No prior prostate cancer treatment including androgen deprivation therapy
4. Male aged 18 or over
5. Considered suitable candidate for radical surgery for prostate cancer
6. Adequate hepatic, bone marrow, coagulation and renal function as defined by the following criteria:
6.1. Haemoglobin > 9.0 g/dL
6.2. Platelets > 100 x 109 L
6.3. Creatinine <2 x ULN
6.4. Hepatic function: total bilirubin = 2 x ULN; ALT and AST = 3 x ULN
6.5. Prothrombin time = 1.5 x ULN; APTT = 1.5 x ULN
7. Willingness to comply with scheduled visits (including an additional PET/CT scan)

Exclusion Criteria

Current participant exclusion criteria as of 09/09/2021:
1. Evidence of demonstrable distant metastasis on standard of care imaging using combination of MRI, CT, isotopic bone scan, non-PSMA PET/CT, or PSMA-PET/CT where undertaken as standard of care
2. Patients not willing to receive surgical treatment with radical prostatectomy and pelvic node dissection
3. Patients who are unable or unwilling to give informed consent

Previous participant exclusion criteria:
1. Evidence of demonstrable metastasis on standard of care imaging using combination of MRI, CT and isotopic bone scan
2. Patients not willing to receive surgical treatment with radical prostatectomy and pelvic node dissection
3. Patients not able to undergo PET/CT scan because of weight (e.g. >180 kg), claustrophobia, or not able to lie still during the scanning duration
4. Patients who already had PSMA PET/CT scan for diagnosis of prostate cancer
5. Patients who are unable or unwilling to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified