Prostate Cancer Brachytherapy Trial, NSW, Recruiting

Trial Review

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Registration number

ACTRN12626000509369p Ethics application status

Submitted, not yet approved Date submitted

10/03/2026 Date registered

23/04/2026 Date last updated

23/04/2026 Date data sharing statement initially provided

23/04/2026 Type of registration

Prospectively registered
Titles & IDs Public title Ultra-hypofractionated external beam radiation therapy with risk-adapted brachytherapy boost in localised prostate cancer Query! Scientific title Ultra-hypofractionated external beam radiation therapy with risk-adapted brachytherapy boost in localised prostate cancer Query! Additional trial identifiers [1] 316683 0 Nil Query! Universal Trial Number (UTN) Query! Trial acronym HYBRID Query! Related trial records Query!
Health condition Health condition(s) studied: Prostate Cancer 340833 0 Query! Condition category Condition code Cancer 336993 336993 0 0 Query! Prostate Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure 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. Query! Intervention code [1] 333361 0 Treatment: Other Query! Description of the comparator or control No control group - single arm study Query! Control group Uncontrolled Query!
Outcomes Primary outcome [1] 344601 0 The rate of freedom from biochemical or clinical failure. This will be assessed as a composite outcome. Biochemical failure is defined by the Phoenix criteria, that is, reaching a prostate-specific antigen (PSA) level of nadir + 2 ng/mL, where nadir is the lowest PSA value achieved after completion of treatment. Clinical failure is defined as histopathological evidence of tumour recurrence, or commencement of any anti-neoplastic therapy (androgen deprivation therapy, salvage radiation therapy, salvage surgery, orchidectomy or other anti-neoplastic therapy) for presumed or confirmed prostate cancer recurrence, or death due to prostate cancer. Query! Timepoint [1] 344601 0 This outcome will be assessed at 12 weeks, 6 months and 12 months post completion of radiation therapy and then annually thereafter until the 10 year mark. The primary timepoint for analysis is the 5-year timepoint. Query! Secondary outcome [1] 458560 0 The rate of cumulative acute grade 2 or higher genitourinary adverse events. Acute adverse events are defined as adverse events occurring from the commencement of radiation treatment to within 90 days of the final radiation treatment. Query! Timepoint [1] 458560 0 This outcome will be assessed on the final day of radiation treatment and at 2 weeks, 4 weeks, 8 weeks and 12 weeks post completion of radiation therapy. Query! Secondary outcome [2] 459457 0 The rate of cumulative acute grade 2 or higher gastrointestinal adverse events. Acute adverse events are defined as adverse events occurring from the commencement of radiation treatment to within 90 days of the final radiation treatment. Query! Timepoint [2] 459457 0 This outcome will be assessed on the final day of radiation treatment and at 2 weeks, 4 weeks, 8 weeks and 12 weeks post completion of radiation therapy. Query! Secondary outcome [3] 459460 0 The rate of prevalence of grade 2 or higher genitourinary adverse events. Query! Timepoint [3] 459460 0 This outcome will be assessed at the 2-year and 5-year timepoints post completion of radiation therapy. Query! Secondary outcome [4] 459461 0 The rate of prevalence of grade 2 or higher gastrointestinal adverse events. Query! Timepoint [4] 459461 0 This outcome will be assessed at the 2-year and 5-year timepoints post completion of radiation therapy. Query!
Eligibility Key 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 Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Males Query! Can healthy volunteers participate? No Query! Key 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 Query!
Study design Purpose of the study Treatment Query! Allocation to intervention Non-randomised trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Query! Masking / blinding Open (masking not used) Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Single group Query! Other design features Query! Phase Not Applicable Query! Type of endpoint/s Safety/efficacy Query! Statistical methods / analysis Query!
Recruitment Recruitment status Not yet recruiting Query! Date of first participant enrolment Anticipated 1/07/2026 Query! Actual Query! Date of last participant enrolment Anticipated Query! Actual Query! Date of last data collection Anticipated Query! Actual Query! Sample size Target 176 Query! Accrual to date Query! Final Query! Recruitment in Australia Recruitment state(s) NSW Query!
Funding & Sponsors Funding source category [1] 321343 0 Hospital Query! Name [1] 321343 0 St George Hospital Query! Country [1] 321343 0 Australia Query! Primary sponsor type Government body Query! Name South Eastern Sydney Local Health District Query! Address Query! Country Australia Query! Secondary sponsor category [1] 324079 0 None Query! Name [1] 324079 0 Query! Address [1] 324079 0 Query! Country [1] 324079 0 Query!
Ethics approval Ethics application status Submitted, not yet approved Query! Ethics committee name [1] 319771 0 South Eastern Sydney Local Health District HREC Query! Ethics committee address [1] 319771 0 https://www.seslhd.health.nsw.gov.au/services-clinics/directory/research-home/ethics Query! Ethics committee country [1] 319771 0 Australia Query! Date submitted for ethics approval [1] 319771 0 17/12/2025 Query! Approval date [1] 319771 0 Query! Ethics approval number [1] 319771 0 Query!
Summary 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. Query! Trial website Query! Trial related presentations / publications Query! Public notes Patients that are eligible for this trial have higher risk, clinically localised prostate cancer. The standard of care treatment for this cohort of patients is a combination of "standard brachytherapy" and external beam radiation therapy. Standard brachytherapy is where a uniform dose is given to the entire prostate regardless of where the tumour is within the prostate.

This present single-arm trial is looking at evaluating the efficacy of a new brachytherapy technique called "risk-adapted brachytherapy". This replaces the "standard brachytherapy" component of the current standard of care treatment while keeping the external beam component as is.

Risk-adapted brachytherapy is where an escalated dose is given to the tumour within the prostate and a reduced dose is given to the remainder of the prostate. The tumour within the prostate is defined using magnetic resonance imaging (MRI) and prostate-specific membrane antigen positron emission tomography (PSMA PET) imaging.

The aggregate results of this trial will be compared to results from relevant previously published studies that have utilised "standard brachytherapy" to determine whether this new "risk-adapted brachytherapy" technique is safe and effective. Query!
Contacts Principal investigator Name 148346 0 Dr George Cosman Query! Address 148346 0 St George Hospital Cancer Care Centre, 30 Gray Street, Kogarah NSW 2217 Query! Country 148346 0 Australia Query! Phone 148346 0 +61 2 9113 4505 Query! Fax 148346 0 Query! Email 148346 0 [email protected] Query! Contact person for public queries Name 148347 0 George Cosman Query! Address 148347 0 St George Hospital Cancer Care Centre, 30 Gray Street, Kogarah NSW 2217 Query! Country 148347 0 Australia Query! Phone 148347 0 +61 2 9113 4505 Query! Fax 148347 0 Query! Email 148347 0 [email protected] Query! Contact person for scientific queries Name 148348 0 George Cosman Query! Address 148348 0 St George Hospital Cancer Care Centre, 30 Gray Street, Kogarah NSW 2217 Query! Country 148348 0 Australia Query! Phone 148348 0 +61 2 9113 4505 Query! Fax 148348 0 Query! Email 148348 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.