Towards Optimal Treatment for High Risk Prostate Cancer
Recruiting · NCT06204341 · Interventional (participants receive a specific treatment) · Lead sponsor: Haaglanden Medical Centre
View the official record on ClinicalTrials.gov →Interventions studied
HYPOPRIME treatment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Haaglanden Medical Centre - Leidschendam, South Holland, Netherlands