None listed
Conditions
Brief summary
This study will evaluate the feasibility of pre-treatment Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) scan and Magnetic Resonance Imaging (MRI) for men with high-risk prostate cancer requiring radiotherapy. Who is it for? You may be eligible to join this study if you are Male, aged 18 years or above and have been assessed as having a high-risk prostate cancer requiring high-dose radiotherapy. In addition, a PSMA PET scan and a MRI will also be used to assessed your eligibility to participate. Study details The PSMA PET scan and the MRI will be used to identify cancer sites prior to the high dose radiotherapy treatment. The radiation oncologist and urologist will use the PSMA PET scan and the MRI to map and than target external beam radiotherapy and brachytherapy towards these cancer sites. Participants will be asked to complete a quality of life survey prior to and at 6 weeks, 3, 6, 12, 24 and 36 months post-radiotherapy to determine quality of life following the procedure. They will also be assessed at 1, 3, 6, 12, 24 and 36 to determine clinical outcomes. A follow up PSMA PET scan and MRI will also be performed at three years post radiotherapy treatment determine if any cancer sites are still present.
Interventions
Men with high-risk prostate cancer requiring high-dose radiotherapy will have a PSMA PET scan and a MRI as part of clinical care and prior to enrollment into the study. The urologist and the radiation oncologist will assess the results of the PSMA PET scan and MRI to determine whether the patient is eligible to participate. If the patient is eligible and consents to participate, the patient will undergo a once only high dose radiotherapy (external beam radiotherapy and brachytherapy) which will
Men with high-risk prostate cancer requiring high-dose radiotherapy will have a PSMA PET scan and a MRI as part of clinical care and prior to enrollment into the study. The urologist and the radiation oncologist will assess the results of the PSMA PET scan and MRI to determine whether the patient is eligible to participate. If the patient is eligible and consents to participate, the patient will undergo a once only high dose radiotherapy (external beam radiotherapy and brachytherapy) which will target the cancer sites that were identified in the PSMA PET scan and the MRI. The dose of the radiotherapy treatment will be at the discretion of the treating radiation oncologist and urologist. The duration of the radiotherapy procedure is usually an hour however, the emission of the radiation occurs over several months following discharge from hospital. The PSMA scan, MRI and the radiotherapy treatment will occur in a participating hospital. The men will also complete a quality of life survey prior to and at 6 weeks, 3, 6, 12, 24 and 36 months after radiotherapy treatment to determine when or whether or not they return to good health. The patient will also be reviewed by their treating doctor at 1, 3, 6, 12, 24 and 36 months post radiotherapy treatment.
Sponsors
The Garvan Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. MRI: PI-RADS 4 or 5 and PSMA: SUV > 3 and 2. Gleason Score 8 to 10 with any PSA and any T stage OR Gleason Score 6 to 7 but with PSA > 20 AND/OR T3-T4 AND/OR N1 on imaging 3. Able to provide written consent
Exclusion criteria
* Women * Lower grade or stage disease * Significant post-TURP intraprostatic defect * Significant lower urinary tract symptoms (LUTS) with an international prostatic symptom score (IPSS) >16 by 2 months prior to implant * PSMA avid disease in bone or viscera * PSMA or MRI evidence of nodal disease above the aortic bifurcation
Outcome results
None listed