None listed
Conditions
Brief summary
This study is investigating the feasibility, safety and effectiveness of delivering targeted radiation therapy using a device with in-built magnetic resonance (MR) imaging to identify and deliver the radiation doses specifically to the prostate tumour. Who is it for? You may be eligible for this trial if you are a male aged 40 years or over, you have been diagnosed with a solid prostate tumour that is appropriate for radiation treatment and the cancer has not spread to any other organs. Participants will also need to be able to undergo MR imaging, additional criteria for MR imaging will apply. Study details Participants will receive radiation to the prostate gland using a Linear Accelerator device with MR imaging capability. The intervention is intended to be delivered as 2 sessions over 2 weeks. Participants will be asked to provide blood samples to check the PSA level throughout the study to assess the response to treatment. Data on prostate specific antigen (PSA) response to treatment, as well as any changes to the participants' urinary/bowel habits and sexual function will also be collected. It is hoped that this study will determine whether an MRI-guided approach to radiotherapy is a feasible, safe and effective method for the treatment of prostate cancer that has not spread to other organs.
Interventions
This study is for patient who have not received prior radiation treatment to the Prostate. The dose of radiation is 26Gray in 2 fractions, given 1 week apart. The treatment will be delivered by a Radiation Oncologist by in the an MRI-guided Linear accelerator (MR-Linac) with continuous MR guidance occurring during radiation treatment. Each treatment will take approximately 60 minutes and PSA and Toxicity toxicity assessments be recorded every 3 months for the first year. then 6 monthly until th
This study is for patient who have not received prior radiation treatment to the Prostate. The dose of radiation is 26Gray in 2 fractions, given 1 week apart. The treatment will be delivered by a Radiation Oncologist by in the an MRI-guided Linear accelerator (MR-Linac) with continuous MR guidance occurring during radiation treatment. Each treatment will take approximately 60 minutes and PSA and Toxicity toxicity assessments be recorded every 3 months for the first year. then 6 monthly until the 5-year follow-up is completed. MRI’s will be performed annually. At 24 months, a PSMA PET and Prostate biopsy will be performed.
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 40yrs or older; WHO performance status 0-2; Life expectancy at least 10 years; biopsy proven adenocarcinoma of the prostate; low or favourable intermediate risk prostate cancer; PSA less than 20 ng/mL ; Gleason score 7; Clinical T stage cT1c - cT2c. Solitary Tumours not more than 20mm in diameter on MRI; Tumour margins visible on MRI; Prostate Volume less than 100cc on TRUS; willing and able to give written informed consent
Exclusion criteria
Inability to undergo MRI scanning due to presence of metal or pacemaker or other reason; Clinical Lymph node or distant metastases; Previous treatment for prostate cancer; Previous pelvic radiation therapy; Medications that can affect PSA in the previous 3 months; individuals who are unable to tolerate prolonged stationary supine position up to 1 hour; Urethral stricture; Inflammatory bowel disease; Invasive malignancy within the last 5 years apart from non melanomatous skin cancer; Patients with baseline impotence scoring 17 or below in the SHIM questionnaire; PAtients with Incontinence demonstrated by ICQC-SF score of greater than 5; Active Urinary tract infection and or prostatitis; Prior Trans urethral resection of the prostate within 6 weeks before Radiation therapy; Current participation in another Clinical Investigation; Inability to meet Organs at risk dose constraints
Outcome results
None listed