Clinical trial · Interventional
A First Step Towards Ultra-hypofractionation for Unfavourable Intermediate and High-risk Prostate Cancer
A First Step Towards Ultra-hypofractionation for Unfavourable Intermediate and High-risk Prostate Cancer: a Prospective Safety and Feasibility Study in Patients With Metastatic Prostate Cancer
- 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)
This study aims to make a first step towards ultra-hypofractionation for high-risk prostate cancer by proving the technical feasibility of margin reduction of the seminal vesicles by combining the intra-fraction fiducial tracking with an online re-planning workflow for each fraction to account for the inter-fraction seminal vesicle motion.
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 |
|---|---|---|---|
| Adaptive radiotherapy according to UPRATE protocol | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- All included patients will be treated according to the treatment protocol: Adaptive radiotherapy according to UPRATE
- interventionNames
- Radiation: Adaptive radiotherapy according to UPRATE protocol
Primary outcomes (1)
- measure
- Feasibility of margin reduction expressed as percentage of underdosage at the seminal vesicles
- timeFrame
- 17 months
- description
- Percentage of patients for which in 0 or 1 fraction out 6 fractions the seminal vesicles were underdosed. Underdosage being defined as 95% of the volume of SV receiving \< 95% of prescribed dose. In the case of unavoidable underdosage of the target on the reference plan, coverage below the achieved coverage in the reference plan will be seen as an underdosed fraction. The margin reduction of the SV is considered feasible when ≥90% of patients received successful treatments.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer * Radiologically proven limited metastatic disease * Referred to the Erasmus MC, after multidisciplinary consensus, for local radiotherapy treatment similar to the STAMPEDE trial * Willing to and capable of personally filling out online questionnaire * Signed written informed consent Exclusion Criteria: * Previous pelvic radiotherapy or surgery for prostate cancer (excluding surgery to improve urinary function in benign prostate hyperplasia, i.e. trans-urethral resection of the prostate or prostatectomy according to Millin or Hryntschak) * According to current clinical protocols at discretion of the treating physician, patients can be excluded in case of, for example, an International Prostate Symptom Score of \>20 or a prostate volume of \>90 milliliters, expecting an unacceptable rise in toxicity rates
References
Publications (0)
Data not yet available