Clinical registry of focal low dose rate brachytherapy to assess disease free progression and quality of life in men with biopsy confirmed low-intermediate risk prostate cancer.

Icon Cancer Foundation0 个研究点目标入组 100 人开始时间: 2019年11月28日最近更新: 2024年5月6日

适应症

试验速览

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•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.

•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.

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