Clinical trial · Interventional
Optimal Prostate Study
Optimal Prostate Fractionation Study
NCT03386045CI-TRIAL-00101915active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the toxicity, rate of local control, biochemical failure rate and quality of life of three different radiotherapy techniques (moderate hypofractionation, stereotactic body radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optimal Booster | Radiation | — | UNRESOLVED |
| Optimal SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Optimal SBRT
- description
- Participants in this group will be randomised to either SBRT ( 36 to 45 GY in 5 fractions) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the SBRT (5 treatments) and one third will get the standard fractions.
- interventionNames
- Radiation: Optimal SBRT
- type
- ACTIVE_COMPARATOR
- label
- Optimal Booster
- description
- Participants in this group will be randomised to either standard radiotherapy plus SBRT (45 Gy in 20 fractions plus 20-30 Gy in 2 fractions-Booster) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the Booster arm and one third will get the standard fractions.
- interventionNames
- Radiation: Optimal Booster
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Histologically proven prostate adenocarcinoma * PSA obtained within three months prior to enrolment * ECOG performance status 0 to 2 * Ability to understand and the willingness to sign a written consent * Suitable for high dose irradiation to the prostate To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following * No contraindication to MRI such as pacemaker and severe claustrophobia * Patient must be able to have fiducial markers placed in the prostate * Patient must be able to have hydrogel insertion at the same time as fiducial markers * Must have IPSS less than 15 Exclusion criteria * Previous pelvic radiotherapy * Prior total prostatectomy * Unwilling or unable to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.