None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the accuracy of PSMA-PET/CT scans for determining the stage of prostate cancer and planning treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer for which you have not yet received treatment, but it is planned that you will undergo surgery or radiotherapy. Study details: All participants enrolled in this trial will be randomly allocated (by chance) to receive either the conventional scans (CT + bone scan), or the PSMA-PET/CT scan which is being evaluated. All patients will cross-over to second-line DI (crossover to other arm) unless the disease status for distant metastases was positive (ie. not equivocal or negative) with >2 sites of disease demonstrated. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the scans will be determined by using follow-up information available up to 6 months after entering the study. If the scans showed abnormalities or your doctor has clinical suspicion of prostate cancer, the scans will be repeated at 6 months. In patients with normal PSMA PET/CT scans, follow-up data may be collected at 18 30, 42 and 54 months (the study will stop 3 years after randomisation of the last patient).
Interventions
Experimental arm: Ga-68 PSMA-PET/CT imaging in place of standard care conventional imaging scan
Patients randomised to the experimental arm will undergo PET/CT imaging following a single intravenous bolus administration of 150 MBq (+/- 50 MBq) of Ga-68-PSMA-11.
Prior to injection, qualified site personnel will assay the dose in the dose calibrator and
record the assay reading and time. The CT and PET imaging session will begin approximately 45 to 75 minutes after injection. The total time in the
Experimental arm: Ga-68 PSMA-PET/CT imaging in place of standard care conventional imaging scan Patients randomised to the experimental arm will undergo PET/CT imaging following a single intravenous bolus administration of 150 MBq (+/- 50 MBq) of Ga-68-PSMA-11. Prior to injection, qualified site personnel will assay the dose in the dose calibrator and record the assay reading and time. The CT and PET imaging session will begin approximately 45 to 75 minutes after injection. The total time in the scanner is around 20 minutes. The result of the scan will be provided to the treating physician who may modify patient management based on the result All patients will cross-over to second-line DI (crossover to other arm) within 14 days from the first line DI unless the disease status for distant metastases was positive (ie. not equivocal or negative) with >2 sites of disease demonstrated. Repeat imaging at 6 months will be performed if (1) initial staging was N1 or M1 (ie. positive for disease in pelvic lymph nodes or distant disease) or (2) Biochemical or clinical suspicion of residual / recurrent disease for those initial N0 M0. After completion of first and second-line imaging, at pre-defined sites, 50 participants will also undergo a whole body MRI . The scan takes around 45 minutes and involves no preparation. In the MRI scanner there is a high magnetic field and all patients need to undergo a thorough safety questionnaire and assessment to ensure that any metallic implants or devices (such as pacemakers, stents, joint replacements or even shrapnel) are compatible and safe within the scanner. The diagnostic accuracy of whole body MRI will be then compared to that of PSMA PET/CT
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Untreated, biopsy-proven adenocarcinoma of the prostate 2. Patient is being considered for curative-intent treatment with radical prostatectomy or radiotherapy 3. Patients must have high-risk features including at least one of the following features: - PSA greater than or equal to 20.0 ng/ml within 12 weeks prior to randomisation - Gleason group 3, 4 or 5 - Clinical stage greater than or equal to T3 4. Age greater than or equal to 18 years 5. Patient has provided written informed consent for participation in this trial 6. In the opinion of investigator, willing and able to comply with required study procedures
Exclusion criteria
1. Participant has had any prior therapy for prostate cancer 2. Participant has undergone, within 8 weeks prior to randomisation, imaging for the primary purpose of staging nodal or distant metastatic disease of prostate cancer (MRI performed for primary purpose of assessing T-stage or to guide biopsy is acceptable) 3. A history of other active malignancy within the last 5 years with exception of non-melanoma skin cancer or melanoma insitu 4. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components 5. Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols
Outcome results
None listed