NCT06204341 Towards Optimal Treatment for High Risk Prostate Cancer
| NCT ID | NCT06204341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haaglanden Medical Centre |
| Condition | High Risk Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 207 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2032-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 207 participants in total. It began in 2024-01-02 with a primary completion date of 2032-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Leonard P Bokhorst, MD, PhD
PRINCIPAL INVESTIGATOR
Haaglanden Medical Centre
Frequently Asked Questions
Who can join the NCT06204341 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying High Risk Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06204341 currently recruiting?
Yes, NCT06204341 is actively recruiting participants. Contact the research team at u.fisscher@haaglandenmc.nl for enrollment information.
Where is the NCT06204341 trial being conducted?
This trial is being conducted at Leidschendam, Netherlands.
Who is sponsoring the NCT06204341 clinical trial?
NCT06204341 is sponsored by Haaglanden Medical Centre. The principal investigator is Leonard P Bokhorst, MD, PhD at Haaglanden Medical Centre. The trial plans to enroll 207 participants.