Focal Radiotherapy for Previously Treated Prostate Cancer Patients

Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate

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

Study Overview

• Status: Recruiting
• Conditions: Locally Recurrent Prostate Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy

Detailed Description

Participants must have biopsy proven locally recurrent prostate cancer. Biopsy will be performed by a Urologist. Participants will have PSMA-PET (prostate-specific membrane antigen and positron emission tomography) scan and MRI in Radiology and Nuclear Medicine by experienced Radiologists in the Royal North Shore Hospital. before starting stereotactic radiotherapy. Participants will require fiducial markers inserted in the prostate and may require hydrogel insertion depending on the location of the recurrence. If these are required, it will be done by experienced radiation oncologists. Fiducial markers insertion involves inserting three gold markers into the prostate. It will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment, Focal Stereotactic Body treatment (SBRT) will be used in the study. There are three groups of participants. Each group will receive different level of radiation dose to test the safety of increasing radiation dose. Group 1 will receive 36 grays (radiation dose unit, Gy)) in 6 treatments. Group 2 will receive 38 grays in 6 treatments and Group 3 will receive 40 grays in 6 treatments. The incremental dose escalation will cease if any excess acute toxicity or late grade 3 toxicity. SBRT will be delivered two to three times per week, every second day. The number of treatments per week will depend on the day of the week participants start their treatment. Participants will be reviewed weekly or second weekly. Toxicity will be recorded. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse events will be reported to the Principal Investigator and Human Research Ethics Committee within 24 hours.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn Kwong; Phone Number: +61 2 9463 1339; Email: carolyn.kwong@health.nsw.gov.au
• Study Contact Backup: Name: Heidi Tsang; Phone Number: +61 2 9463 1340; Email: heidi.tsang@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
      • Contact: Clare Banks, RN; Phone Number: +6129463 1340; Email: heidi.tsang@health.nsw.gov.au
      • Contact: Carol Kwong, RN; Phone Number: +6129463 1339; Email: carolyn.kwong@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; This group of 12 patients will be given 36Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.	Radiation: Stereotactic Body Radiotherapy; Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.
Other: Group 2; This group (12 patients) will be given 38Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.	Radiation: Stereotactic Body Radiotherapy; Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.
Other: group 3; This group (12 patients) will be given 40Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.	Radiation: Stereotactic Body Radiotherapy; Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved	at weekly review through completion of each radiothrapy dose level, approximately one year
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	outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation	at weekly review through completion of each radiothrapy dose level, approximately one year
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.	outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation	at weekly review through completion of each radiothrapy dose level, approximately one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of conservation dose escalation in this cohort of patients	outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation	After each group of patients have completed radiotherapy and at 12 and 24 months follow-up. Patients will have routine follow-up 6 monthly for 1 year and then yearly for 10 years post treatment. But study outcomes will only be collected for 2 years.

Collaborators and Investigators

• Sponsor: Royal North Shore Hospital
• Collaborators: Northern Sydney and Central Coast Area Health Service
• Investigators: Principal Investigator: George Hruby, Northern Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: Focal SBRT prostate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: aim to present data in conferences and publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No