Focal Radiotherapy for Previously Treated Prostate Cancer Patients

NCT03073278 · tracked via the Priya Life Science Australia tracker

Sponsor

Royal North Shore Hospital

Phase

Not applicable

Started

2017-04-24

Last updated

2026-02-06

Condition(s) studied

Locally Recurrent Prostate Cancer

Investigational drug(s) / intervention(s)

Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy: Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

Study summary

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Men \> 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men \> 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used * Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a) * Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region. * Life expectancy at least 10yrs from time of SBRT * PSA \< 10 Exclusion Criteria: * Recurrence in immediate proximity to rectum (unless able to have hydrogel) * Grade 3 or more toxicity from previous EBRT * Contra-indicated for fiducial insertion * GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)

Primary outcome measure(s)

feasibility of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 — at weekly review through completion of each radiothrapy dose level, approximately one year
acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved
safety of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 — at weekly review through completion of each radiothrapy dose level, approximately one year
outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation
Toxicity. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 and RTOG toxicity score. — at weekly review through completion of each radiothrapy dose level, approximately one year
outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation

Trial sites (1)

Facility	City	Region	Status
Royal North Shore Hospital	St Leonards	New South Wales	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03073278 on ClinicalTrials.gov ↗ ← All trials in Australia