None listed
Conditions
Brief summary
The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult male over the age of 18 who has been diagnosed with intermediate or high risk prostate cancer . Study details Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In schedule 1 (called Sterotactic Body Radiotherapy) participants will receive 5 radiotherapy treatments over 2 weeks and in schedule 2 (called Virtual High Dose Rate Boost) participants will receive Sterotactic Body Radiotherapy delivered in 2 treatments over 1 week followed by 12 treatments of conventional external beam radiotherapy over 2 and a half weeks. A blood test will be collected at the initial assessment, 6 weeks after radiotherapy and 6 monthly for a period of 5 years. Questionnaires will completed at the initial assessment, 6 weeks after radiotherapy and at 2 and 5 years. It is hoped that this research will potentially improve the accuracy and quality of radiotherapy treatment in prostate cancer.
Interventions
ARM 1: Stereotactic Body Radiotherapy (SBRT) Monotherapy: 40Gy in 5 fractions delivered 1-3x/week (typically 5 treatments given over 2 weeks)
ARM2: Virtual High Dose Rate Brachytherapy (HDRB) Boost: 20gy in 2 fractions delivered once a week followed by a 2 week break and then 36Gy in 12 fractions delivered 4-5x/week. (2 treatments given 1 week apart, combined with a shorter version of conventional external beam radiotherapy)
All participants irrespective of the radiotherapy treatment arm they a
ARM 1: Stereotactic Body Radiotherapy (SBRT) Monotherapy: 40Gy in 5 fractions delivered 1-3x/week (typically 5 treatments given over 2 weeks) ARM2: Virtual High Dose Rate Brachytherapy (HDRB) Boost: 20gy in 2 fractions delivered once a week followed by a 2 week break and then 36Gy in 12 fractions delivered 4-5x/week. (2 treatments given 1 week apart, combined with a shorter version of conventional external beam radiotherapy) All participants irrespective of the radiotherapy treatment arm they are allocated will commence 6 months of androgen deprivation therapy (ADT) prior to receiving radiotherapy (approximately 3 to 4 months prior). ADT is given via injection and is considered part of the standard of care for participants eligible for this study. The dose, frequency and administration is dependent on that prescribed by the clinician. This study will also look at better ways in which we can plan radiotherapy treatment for men with prostate cancer using Magnetic Resonance Imaging (MRI scans) for radiotherapy planning.
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Unfavourable intermediate or low-high risk prostate cancer - ISUP 2 AND EITHER PSA 10-20, OR T2b/c AND greater than or equal to 50% Biopsy Cores Positive - ISUP 3 AND PSA less than or equal to 20 OR - ISUP 4-5 (NOT predominant pattern 5 disease) OR T3a AND PSA less than and equal to 20 Staging investigations showing N0M0 disease performed within 60 days prior to commencing ADT or antiandrogen: - For high risk patients, PSMA PET staging within 60 days prior to study entry showing N0M0 disease. - For unfavourable intermediate risk patients, either PSMA PET alone OR whole body bone scan AND EITHER CT abdomen/pelvis OR MRI prostate/pelvis. Histologically confirmed prostate cancer ECOG performance status of 0-1. Life expectancy greater than 5 years.
Exclusion criteria
Higher risk prostate cancer: - T3b or T4 based on all clinical information available including examination and investigations - PSA greater than 20 - Dominant pattern 5 histology (ie Gleason score 5+4 or 5+5) Previous pelvic radiotherapy Prior diagnosis of cancer that was: - more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10% - within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix Patients with clinical evidence of metastatic disease. Presence of total hip joint replacement Clinical Target volume greater than 100cc Severe obstructive lower urinary tract symptoms (IPSS greater than an equal to 20) Any contraindications to performance of a planning MRI
Outcome results
None listed