Focal Radiotherapy for Previously Treated Prostate Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Body Radiotherapy.
- Who it may be relevant to
- Registry conditions: Locally Recurrent Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
Overview
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.
Interventions
- 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
- 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]
- 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]
- 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]
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.]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Royal North Shore Hospital — St Leonards
Identifiers
NCT: NCT03073278 · Focal SBRT prostate