Clinical registry of focal low dose rate brachytherapy in men with biopsy confirmed low-intermediate risk prostate cancer (LIBERATE)

Trial summary:

This study aims to establish a clinical registry, encompassing patient data from men with prostate cancer undergoing focal LDR brachytherapy.

Principal Investigators: Icon Cancer Centre Radiation Oncologist Dr Andrew See and Epworth Healthcare Urologic Surgeon A/Prof Jeremy Grummet

Receptor status / problem studied:

Prostate cancer

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 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).

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

View more trial information

Open for recruitment

Trial Title



Prostate cancer

Type of trial

Investigator Initiated

Type of treatement

Radiation Oncology Radiation Medicine




Principal Investigator
View all clinical trials


Contact us
Become a patient