None listed
Conditions
Brief summary
What is the purpose of this study? This study is aiming to evaluate whether risk-adapted brachytherapy to the prostate, as opposed to standard brachytherapy, improves prostate cancer outcomes and reduces side effects for patients. Who is it for? Patients with localised prostate cancer, who have higher risk disease, where a combination of external beam radiation therapy and brachytherapy is recommended, are eligible to enroll onto this study. What are the details? All participants enrolled onto the study will receive the investigative treatment (risk-adapted brachytherapy) and have regular follow-up after treatment completion to assess treatment outcomes and side effects. Follow-up after treatment completion is similar to what you would have if you were not on this study and includes regular visits with your treating oncologist and regular PSA blood tests. If results from this study are favourable, it is hoped that future patients with prostate cancer will be able to have more effective radiation treatment with less side effects.
Interventions
Risk-Adapted Brachytherapy + External Beam Radiation: An escalated dose of 18Gy is given to the tumour within the prostate and a reduced dose of 12Gy is given to the remainder of the prostate in a single treatment (three hour procedure). The tumour within the prostate is defined using magnetic resonance imaging (MRI) and prostate-specific membrane antigen positron emission tomography (PSMA PET) imaging. This is followed by a course of external beam radiation treatment. A total dose of 25Gy is de
Risk-Adapted Brachytherapy + External Beam Radiation: An escalated dose of 18Gy is given to the tumour within the prostate and a reduced dose of 12Gy is given to the remainder of the prostate in a single treatment (three hour procedure). The tumour within the prostate is defined using magnetic resonance imaging (MRI) and prostate-specific membrane antigen positron emission tomography (PSMA PET) imaging. This is followed by a course of external beam radiation treatment. A total dose of 25Gy is delivered to the entire prostate and the surrounding regions in five treatments over a period of one to two weeks. Each treatment takes about half an hour. The treatments are administered by the treating radiation oncologist. Treatment adherence is monitored by the clinical trial team by review of dosimetry data.
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age >= 18 Histologically confirmed prostate adenocarcinoma Clinically localised disease Unfavourable intermediate OR High OR Very high risk disease as per national comprehensive cancer network (NCCN) risk stratification (Version 4.2026) Intraprostatic tumour visible on MRI and/or PSMA PET imaging Technically implantable prostate
Exclusion criteria
T4 or N1 or M1 disease on PSMA PET or MRI Volume of intraprostatic tumour > 40% of prostate volume Prior transurethral resection of prostate (TURP) Prior pelvic radiation therapy
Outcome results
None listed