RecruitingPhase 1ACTRN12617000035325

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

Sponsor

Northern Sydney Local Health District-Royal North Shore Hospital

Enrollment

36 participants

Start Date

Apr 24, 2017

Study Type

Interventional

Conditions

locally recurrent prostate cancer following definitive external beam radiotherapy

Summary

The aim of the study is to examine the feasibility, safety and toxicity of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer following definitive external beam radiotherapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with biopsy proven locally recurrent prostate cancer. Study details All participants in this study will first receive two different types of scans to locate the suspected regions of recurrence – these scans are called prostate-specific membrane antigen positron emission tomography (PSMA-PET) and magnetic resonance imaging (MRI). They will then proceed to receive six treatment sessions of Stereotactic Body Radiation Therapy (SBRT). The first 12 participants will receive a radiation dose of 36 grays (radiation dose unit). If this is tolerated, then the next 12 participants will receive a dose of 38 grays. Again if this is tolerated, then the final 12 participants will be treated at a dose of 40 grays. After treatment, all participants will have follow-up every 4 months for the first two years, After two years patients will have routine follow-up (6 monthly for one year, then yearly thereafter until 10 years). During the follow-up period, Patients will have PSA and toxicity assessments. PSMA-PET scans will be repeated at 12 and 24 months post treatment. Study related outcomes will be collected for 2 years. After 2 years outcomes will be collected as per departmental protocol. The study aims to combine the non-invasive advantages of SBRT re-irradiation using functional MRI plus PSMA-PET scans to define and treat the area of recurrence rather than the whole prostate gland.

Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for men who had prostate cancer treated with radiation therapy years ago, but the cancer has come back in a limited area of the prostate. The study tests a focused type of re-radiation treatment called SBRT (Stereotactic Body Radiation Therapy), which targets only the part of the prostate where the cancer returned — rather than the whole gland — to reduce side effects. Participants receive 6 treatment sessions over several weeks and are then followed for up to 10 years. You may be eligible if: - You are male, 18 years or older - Your prostate cancer was treated with radiation therapy at least 4 years ago (or 5 years if hormone therapy was also used) - Your cancer has come back, as proven by a biopsy, and is limited to less than half the prostate - Your PSA level is below 15 - Your life expectancy is at least 10 more years You may NOT be eligible if: - The recurrent cancer is very close to the rectum (unless a protective gel spacer can be placed) - You had serious side effects from your original radiation treatment - You cannot have fiducial markers (small gold seeds) placed in the prostate - You previously had a very aggressive cancer (Gleason score 8, 9, or 10) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants must have biopsy proven locally recurrent prostate cancer. Biopsy will be performed by a Urologist. Participants will have PSMA-PET 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. There will be three groups of participants, each group will receive different level of radiation dose to test the safety of increasing radiotherapy dose. Group 1 will receive 36 grays (radiation dose unit) 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 or late grade 3 toxicity. Focal Stereotactic body radiation treatment (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 you start your treatment (ie ,if you start your radiotherapy on Wednesday, you will have two treatments that week etc). You will have a total of 6 treatments. Each radiotherapy session will take 30 minutes. Patients 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 HREC within 24 hours.

Locations(1)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12617000035325