None listed
Conditions
Brief summary
This study aims to establish a clinical registry, encompassing patient data from men with prostate cancer undergoing focal LDR brachytherapy. Who is it for? You may be eligible for this study if you are man aged between 40 and 85, with a diagnosis of Prostate cancer, clinical stage T1c or T2a. Study details The study visits will be 6 weeks following treatment, then three-monthly for 24 months following treatment, then six-monthly until five years following treatment. At these visits, various clinical assessment and blood tests will be performed. In addition, the study will also involve collecting data from multi-parametric-MRI scans, biopsies and questionnaires relating to quality of life and functional outcomes, particularly in the domains of urinary, gastro-intestinal and sexual function. It is hoped that the registry can establish an evidence base for the national uptake of focal LDR brachytherapy, in addition to provider greater insight into the global body of data regarding primary focal therapy for PCa.
Interventions
Enrolled participants will undergo a pre-plan volume study for the purpose of brachytherapy planning, followed by seed implantation 4-12 weeks later. Post-implantation, a non-contrast CT scan and/or MRI of the true pelvis will be acquired for the purpose of assessing implant quality and determining dose to organs at risk.
mp-MRI (T1/2, DWI, DCE) or PSMA PET - Pre-treatment and again at 18 to 36 months at the discretion f the treating physician.
TPM biopsy - Pre-treatment and again at 18 to 36
Enrolled participants will undergo a pre-plan volume study for the purpose of brachytherapy planning, followed by seed implantation 4-12 weeks later. Post-implantation, a non-contrast CT scan and/or MRI of the true pelvis will be acquired for the purpose of assessing implant quality and determining dose to organs at risk. mp-MRI (T1/2, DWI, DCE) or PSMA PET - Pre-treatment and again at 18 to 36 months at the discretion f the treating physician. TPM biopsy - Pre-treatment and again at 18 to 36 months at the discretion of the treating physician. Assess eligibility criteria - pre-treatment Review medical history - pre-treatment Review medications - pre-treatment Clinical assessment - pre-treatment and every visit up to 5 years Informed consent - pre-treatment PSA Assessment - pre-treatment and every visit up to 5 years Focal LDR brachytherapy Next day post-implant CT/MRI* - one day after LDR Post-implant dosimetry - one day after LDR Acute toxicities (CTCAE) - pre-treatment and again 6 weeks, and 3 months after treatment Late toxicities (CTCAE) - 6,9, 12, 15, 18, 21 and 24 months after treatment then every 6 months up to 5 years Questionnaires - pre-treatment, 6 weeks, 6 months, 12, 18, and 24 months then every 6 months up to 5 years. Enrolment is projected to be completed in 60 months after opening. The follow-up period will be completed at up to 60 months after the last participant has been enrolled. If patient meets progression, the following will be completed; mp-MRI (T1/2, DWI, DCE) or PSMA PET TPM biopsy Clinical assessment PSA Assessment
Sponsors
Icon Cancer Foundation
Eligibility
Sex/Gender
Male
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
• Men 40-85 years of age (inclusive). • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. • Life expectancy more than 10 years based on co-morbidity not related to prostate cancer. • Prostate specific antigen (PSA) level less than or equal to 10 ng/ml. • Prostate cancer clinical stage T1c or T2a. • PIRADS score of 3-5 (inclusive) or suspicious prostate lesion of PSMA PET. • Reproducible template biopsy of the prostate gland demonstrating: - Histologically-proven index lesion Gleason 6 (greater than or equal to 10mm in greater than or equal to 1 core) or 7 (3+4) or 7 (4+3) (longest core < 10mm) adenocarcinoma coinciding with mp-MRI; - Template biopsies of the remaining gland, with minimum 18 cores taken for <40cc prostate and 24 cores for 40-60cc prostate; and - Non sector positive prostate containing no cancer or clinically insignificant cancer (cancer core length <10mm Gleason 3+3). • No significant urinary obstructive symptoms. • Able to participate in the stipulated follow-up (either telephone follow-up or on-site visits acceptable, but one follow-up annually should be in person). • Patients or their legal representatives must have the ability to read, understand and provide written informed consent.
Exclusion criteria
• Evidence or suspicion of extra-capsular extension on MRI. • Prostate cancer with significant sarcomatoid, ductal, spindle cell or neuroendocrine small cell components. • Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. • Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer. • Any anatomical abnormality or medical condition precluding brachytherapy planning or treatment, or follow-up imaging (i.e. unable to cease anti-coagulant therapy, contraindications to anaesthesia, imperforate anus, TURP defect, diffuse intra-prostatic calcification, unfavourable prostatic geometry etc.) • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition. • Patients who have received, or are receiving, any form of localised or systemic treatment (including ADT) for prostate carcinoma (excluding 5a-reductase inhibitors). • Patients who are unwilling or unable to adhere to study requirements, including treatment and required assessments.
Outcome results
None listed