Locally Recurrent Prostate CancerNCT03073278
Focal Radiotherapy for Previously Treated Prostate Cancer Patients
A study testing Stereotactic Body Radiotherapy in people with Locally Recurrent Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Locally Recurrent Prostate Cancer
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Apr 2017to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Carol Kwong, RN, +6129463 1339, carolyn.kwong@health.nsw.gov.au
Clare Banks, RN, +6129463 1340, heidi.tsang@health.nsw.gov.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Locally Recurrent Prostate Cancer
- Being tested
- Stereotactic Body Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start24 Apr 2017
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Responsible party
- Sponsor
- Investigators
- George Hruby, Principal investigator, Northern Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073278
- Sponsor's protocol ID
- Focal SBRT prostate
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: aim to present data in conferences and publications
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
- ClinicalTrials.gov ID
- NCT03073278
- Acronym / sponsor ID
- Focal SBRT prostate
- Conditions
- Locally Recurrent Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Radiation: Stereotactic Body RadiotherapyThis 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. |
| Group 2 | Other | Radiation: Stereotactic Body RadiotherapyThis 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. |
| group 3 | Other | Radiation: Stereotactic Body RadiotherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body RadiotherapyEach group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in. | Radiation | Group 1, Group 2, group 3 |
Primary outcome
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
Time frame: 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
Time frame: 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.
Time frame: 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
1 secondary outcome
Tolerability of conservation dose escalation in this cohort of patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. aim to present data in conferences and publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Hruby principal investigator
Northern Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy in people with Locally Recurrent Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Kwong (+61 2 9463 1339, carolyn.kwong@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: at weekly review through completion of each radiothrapy dose level, approximately one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.