Clinical trial · Interventional
BIOPROP20: Biologically Optimised IMRT for Prostate Radiotherapy Hypofractionated Radiotherapy With Intra-prostatic Boosts to Tumour Nodules in Men With Intermediate and High Risk Prostate Cancer
NCT02125175CI-TRIAL-00041334BIOPROP20completedN/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)
High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose to the rest of the prostate. This may improve control of the cancer without increasing the side effects. The radiotherapy is given in 20 doses, called fractions.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated IMRT boost Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated IMRT boost Radiotherapy
- interventionNames
- Radiation: Hypofractionated IMRT boost Radiotherapy
Primary outcomes (1)
- measure
- Acute bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment
- timeFrame
- 18 weeks
Secondary outcomes (2)
- measure
- The success rate of producing dose painted IMRT plans which fulfill the dose-volume constraints as specified for the prostate and for the normal tissues
- timeFrame
- 3 years
- measure
- Late bladder and bowel toxicity (NCI CTCAE v4) at 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. NCCN intermediate/high risk disease and estimated risk of lymph node involvement 15 - 40%\* 3. MRI stage T2a-T4 N0M0 4. Age 18-80 years 5. Normal blood count (Hb \>11g/dl, WBC \> 4000/mm3, platelets \>100,000/mm3) 6. WHO performance status 0 or 1 7. Fully informed written consent * Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA Exclusion Criteria: 1. Prior radiotherapy to the prostate or pelvis 2. Prior hormone therapy or radical prostatectomy 3. Total hip replacement 4. Clinically significant inflammatory bowel disease 5. Contraindication to have diagnostic MRI scans 6. Unable to have a general anaesthetic 7. Anti-coagulant therapy which cannot be temporarily stopped
References
Publications (2)
- DERIVEDChatterjee R, Chan J, Mayles H, Cicconi S, Syndikus I. Long-term Results of Hypofractionated Radiotherapy With Intra-prostatic Boosts in Men With Intermediate- and High-risk Prostate Cancer: A Phase II Trial. Clin Oncol (R Coll Radiol). 2024 Dec;36(12):e473-e482. doi: 10.1016/j.clon.2024.08.011. Epub 2024 Aug 22. PMID 39242247
- DERIVEDOnjukka E, Uzan J, Baker C, Howard L, Nahum A, Syndikus I. Twenty Fraction Prostate Radiotherapy with Intra-prostatic Boost: Results of a Pilot Study. Clin Oncol (R Coll Radiol). 2017 Jan;29(1):6-14. doi: 10.1016/j.clon.2016.09.009. Epub 2016 Sep 29. PMID 27692920