LIBERATE

• 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 10 ng/ml
• Prostate cancer clinical stage T1c or T2a
• Prostate size less than 60cc on multi-parametric MRI (T1W/T2W, diffusion-weighting and dynamic contrast enhancement)
• PIRADS score of 3-5 (inclusive)
• Reproducible template biopsy of the prostate gland demonstrating:
  Histologically-proven index lesion Gleason 6 (=10mm in =1 core) or 7 (3+4) adenocarcinoma coinciding with mp-MRI identified lesion;
  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)
• IPSS score = 15
• Men with an IPSS score of 8 to 15 (inclusive) must have a urinary flow (Qmax = 10ml/sec) and residual volume = 150ml with voided volume >150ml
• 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 (TBC – see informed consent section).

• 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.
• Patients opt-out of participating in the registry in writing

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