NCT06204341Recruiting
Towards Optimal Treatment for High Risk Prostate Cancer
Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 207 (estimated)
- First submitted
- 3 Jan 2024
- Start date
- 2 Jan 2024
- Primary completion date
- 18 Dec 2032
- Lead sponsor
- Haaglanden Medical Centre
- Diseases
- Prostate cancer
- NCT number
- NCT06204341
What you commit to
- Study type: Interventional
- Planned participants: 207
- From 2 Jan 2024 to the primary completion date, 18 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy
- TransUrethral Resection of the Prostate (TURP) \< 3 months ago
Other illness
- Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)
- inflammatory bowel disease
- metastatic disease (M1)
- medical history of cancer other than basal cell carcinoma of the skin
Other
- contraindications to MRI
- no visible lesion on MRI in prostate for boost
- no PSMA-PET scan
- PSA \>50
- unsuitable for SBRT or WPRT
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haaglanden Medical Centre Coordinator of this site? Confirm its status | Leidschendam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.