Status:
ACTIVE_NOT_RECRUITING
A First Step Towards Ultra-hypofractionation for Unfavourable Intermediate and High-risk Prostate Cancer
Lead Sponsor:
Erasmus Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 int...
Detailed Description
Rationale: One of the key treatment modalities for prostate cancer is external beam radiation therapy. Considering the relatively low alpha/beta ratio of prostate cancer, increasing the dose per frac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05361902
Start Date
July 7 2022
End Date
February 1 2027
Last Update
August 28 2024
Active Locations (1)
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1
Erasmus Medical Centre
Rotterdam, South Holland, Netherlands, 3015