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Trial record 1 of 1 for:    NCT03073278
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Focal Radiotherapy for Previously Treated Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT03073278
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
A/Prof. George Hruby, Royal North Shore Hospital

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

Condition or disease Intervention/treatment Phase
Locally Recurrent Prostate Cancer Radiation: Stereotactic Body Radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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. ]
    outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073278


Contacts
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Contact: Carolyn Kwong +61 2 9463 1339 carolyn.kwong@health.nsw.gov.au
Contact: Heidi Tsang +61 2 9463 1340 heidi.tsang@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Carol Kwong, RN    +6129463 1339    carolyn.kwong@health.nsw.gov.au   
Contact: Clare Banks, RN    +6129463 1340    heidi.tsang@health.nsw.gov.au   
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: George Hruby Northern Sydney Local Health District
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Responsible Party: A/Prof. George Hruby, Principal Investigator, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT03073278    
Other Study ID Numbers: Focal SBRT prostate
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: aim to present data in conferences and publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases