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Brief Title: Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source
Official Title: Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source - The Introduction of Prostate Cancer Targeted Focal Therapy Treatment in Denmark
Study ID: NCT06080113
Brief Summary: The purpose is to assess and describe the oncological and functional outcomes following the introduction of curative targeted focal brachytherapy of prostate cancer in Denmark. Men with a single MRI-identifiable prostate cancer index-tumour who fulfil inclusion criteria and are candidates for curative treatment. Eligible men will undergo curative intended targeted focal brachytherapy for treatment of histologically confirmed prostate cancer. The intervention will include Low- (LDR) or High (HDR) dose rate targeted focal brachytherapy of prostate cancer. Collection of data on safety, morbidity, side effects and quality of life. Collection of clinical data on treatment efficacy, progression, and mortality. All patients will have a follow up of 10-years for oncological outcome, 5-years for acute- and late toxicity-, and 2-years for functional outcomes, respectively. The follow up will include clinical data, MRI, confirmatory biopsies, and questionnaires at specific fixed time points pre-and post-operatively after 1-3 days, 4-weeks, 3-, 6--, 9-, 12-, 18-, and 24-months followed by every 6 months up to 5-yr and then every year up to 10-yr follow-up. Anticipated number of patients is 50 and regular analysis and reporting will be performed continuously. The first short-term analysis will be after 18-months of follow-up after confirmatory MRI and biopsies, and the final reporting will be after 10-years follow-up in 2035.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Department of Urology, Herlev University Hospital Herlev, Herlev, , Denmark
Name: Lars Boesen, MD,PhD,DMSci
Affiliation: Department of Urology
Role: PRINCIPAL_INVESTIGATOR