Clinical trial · Interventional
Towards Optimal Treatment for High Risk Prostate Cancer
Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
- 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)
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments. * patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation) * the tumor will get a higher dose * androgen deprivation therapy will be reduced as much al possible preventing side effects Researchers will compare oncological outcome and toxicity.
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 |
|---|---|---|---|
| High Risk Prostate Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HYPOPRIME treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HYPOPRIME treatment
- description
- Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy
- interventionNames
- Radiation: HYPOPRIME treatment
Primary outcomes (2)
- measure
- Biochemical recurrence free survival
- timeFrame
- 5 years
- description
- rise of PSA 2 ng/ml above nadir
- measure
- Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction
- timeFrame
- at 6 months and 2 years
- description
- according to CTC-AE v5
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men (aged ≥18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer: * T3 based on digital rectal examination AND/OR * Grade \>= 4 AND/OR * PSA \>=20 ug/L * Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes) Exclusion Criteria: * Prior pelvic radiotherapy * TransUrethral Resection of the Prostate (TURP) \< 3 months ago * Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc) * contraindications to MRI * no visible lesion on MRI in prostate for boost * no PSMA-PET scan * inflammatory bowel disease * metastatic disease (M1) * PSA \>50 * unsuitable for SBRT or WPRT * medical history of cancer other than basal cell carcinoma of the skin
References
Publications (0)
Data not yet available