Status:
RECRUITING
Towards Optimal Treatment for High Risk Prostate Cancer
Lead Sponsor:
Haaglanden Medical Centre
Collaborating Sponsors:
Tata Memorial Centre
Conditions:
High Risk Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 w...
Detailed Description
Rationale: Recently several randomized trial have shown benefits of changes made to radiotherapy of (high risk) localized prostate cancer patients: A focal boost was shown to improve outcome in men wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2032
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT06204341
Start Date
January 2 2024
End Date
December 18 2032
Last Update
September 19 2024
Active Locations (1)
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1
Haaglanden Medical Centre
Leidschendam, South Holland, Netherlands, 2262 BA