Focal Radiotherapy for Previously Treated Prostate Cancer Patients

NCT03073278 | Recruiting DMC

• 1 other identifier: Focal SBRT prostate
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Locally Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Tolerability of conservation dose escalation in this cohort of patients

  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.

Study Arms (3)

Group 1

OTHER

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

Group 2

OTHER

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

group 3

OTHER

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

Interventions

Stereotactic Body Radiotherapy RADIATION

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

Group 1; Group 2; group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Northern Sydney and Central Coast Area Health Service: collaborator

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• George Hruby

  Northern Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Kwong

CONTACT

+61 2 9463 1339; carolyn.kwong@health.nsw.gov.au

Heidi Tsang

CONTACT

+61 2 9463 1340; heidi.tsang@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 will receive 36 grays (radiation dose unit Gy) in 6 treatments. Group 2 will receive 38 grays (Gy) in 6 treatments and Group 3 will receive 40 grays (Gy) in 6 treatments. If the first group of participants tolerate the treatment well and with minimal side effects, then the next group of participants will be given the same treatment but at the higher dose (38 Gy). If the second group tolerates this higher dose, then the third group of patients will be given a higher dose (40 Gy). This will be the final dose being tested in this investigation.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 8, 2017
• Study Start: April 24, 2017
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)