Prostate Cancer
Conditions
Keywords
Prostate Cancer, NCCN Low Risk, NCCN Favorable Intermediate Risk
Brief summary
The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
Detailed description
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.
Interventions
RADIATIONMR-Guided SBRT
MR-Guided SBRT
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Optimal Inclusion Criteria * Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria . * No prior radiation therapy to the target areas * Expected patient survival \>5 years * Patient able to undergo a MRI exam Cautionary Inclusion Criteria * Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, \>60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications. * Patients with higher risk but low volume disease not candidates for ENI may be treated on an individual basis
Exclusion criteria
* Prior radiation therapy to the target areas * Expected patient survival below 5 years * Patient unable to undergo a MRI exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Relapse-Free Survival | 5-years | To achieve a 4-year biochemical relapse-free survival of 95%. |
| Adverse Events | 5-years | To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) assessment | 5-years | Determination of QOL with International Prostate Symptom Score (IPSS) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-PR25. IPSS ranges from 0 to 35 with higher values representing worse functioning. EORTC QLQ PR-25 ranges from 0-100 with higher values representing better functioning. |
Contacts
Primary ContactBeatriz Ramos Aguirre, M.S.
Outcome results
None listed