None listed
Conditions
Brief summary
This trial aims to compare four different radiotherapy treatment approaches for prostate cancer using a technique called "Stereotactic Body Radiotherapy" or SBRT to find out which has the best outcomes and least amount of side effects. The treatment approaches will look at two different schedules, either 5 treatments over 2 weeks or 2 treatments over 2 weeks, as well as whether a reduced radiotherapy dose can be used (called "de-escalated" treatment). Who is it for? You may be eligible for this trial is you are aged 18 years or older, have been diagnosed with prostate cancer that your doctor classifies as "intermediate risk" and are suitable for treatment with SBRT. Study details Participants who meet the eligibility criteria will be randomly assigned to one of the four treatment approaches. There is an equal chance of receiving each group. These include: Group 1: SBRT given in 5 treatments over 2 weeks with standard dose to the whole prostate Group 2: SBRT given in 5 treatments over 2 weeks with de-escalated dose to the prostate Group 3: SBRT given in 2 treatments over 2 weeks with standard dose to the whole prostate Group 4: SBRT given in 2 treatments over 2 weeks with de-escalated dose to the prostate During and after treatment for up to 5 years, participants will be asked to complete questionnaires about their quality of life related to prostate cancer as well as report on any side effects of treatment to the trial staff. The trial staff will also access participants' medical records to check whether there have been any signs the cancer has returned such as blood test results, imaging scan results and if any new treatment has been started. It is hoped that this trial will help to determine which radiotherapy approach is best for treating prostate cancer with the smallest amount of side effects. The results will help inform a future larger trial of these treatments that may definitively answer this question.
Interventions
This is a prospective, multicentre, randomised, phase II clinical trial with a 2×2 factorial design of Stereotactic Body Radiotherapy (SBRT) for patients with intermediate risk prostate cancer. Participants will be randomised to receive either standard or reduced whole-gland radiotherapy delivered using either a standard 5-fraction regimen or an experimental 2-fraction regimen. The study is designed to evaluate feasibility, quality of life and safety prior to progression to later-phase efficacy
This is a prospective, multicentre, randomised, phase II clinical trial with a 2×2 factorial design of Stereotactic Body Radiotherapy (SBRT) for patients with intermediate risk prostate cancer. Participants will be randomised to receive either standard or reduced whole-gland radiotherapy delivered using either a standard 5-fraction regimen or an experimental 2-fraction regimen. The study is designed to evaluate feasibility, quality of life and safety prior to progression to later-phase efficacy evaluation. Participants will be randomised to one of four treatment arms in a 1:1:1:1 ratio: Arm A: 5 fraction standard dose (36.25 Gy with index lesion boost to 42 – 45 Gy) Arm B: 5 fraction whole gland dose de-intensification (30 Gy with index lesion boost to 42 – 45 Gy) Arm C: 2 fraction standard dose (24 Gy with index lesion boost to 28 – 30 Gy) Arm D: 2 fraction whole gland dose de-intensification (20 Gy with index lesion boost to 28 – 30 Gy) Arm A and B will receive 5 treatments over 2 weeks with 2-3 treatments per week given on alternate days. Arm C and D will receive 2 treatments over 2 weeks with one treatment per week. For all arms, each treatment session will take approximately 30-60 minutes. The exact dose of the index lesion boost will be determined according to individual patient characteristics and clinician discretion. All radiotherapy will be delivered using SBRT techniques on a linear accelerator by a radiation therapist under the supervision of a radiation oncologist. Adherence to the assigned intervention will be monitored via review of clinic notes during routine monitoring visits.
Sponsors
GenesisCare
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed intermediate risk prostate cancer - Identifiable index lesion(s) (either based on Prostate Specific Membrane Antigen (PSMA) and/or Magentic Resonance Imaging (MRI): Prostate Imaging Reporting and Data System (PIRADS) 4-5) - Eastern Cooperative Group (ECOG) performance status 0-2 - PSMA Positron Emission Tomography (PET) staging investigations showing N0M0 disease performed within 60 days prior or 30 days following commencement of androgen deprivation therapy (ADT)/registration or antiandrogen. - Suitable for real-time motion management
Exclusion criteria
- Any contraindications to performance of a planning MRI - Prior pelvic radiotherapy - Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score (IPSS) of 20 or more) - Comorbidities which predispose to significant radiotherapy toxicities (e.g., inflammatory bowel disease at discretion of treating Radiation Oncologist) - Unilateral or bilateral hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging. - Inability to satisfy dose constraints - Patients with clinical evidence of N1 and/or M1 disease - Any high risk prostate cancer
Outcome results
None listed