Combining advanced treatments for high risk prostate cancer
Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
This study is testing a new treatment approach for men with high risk prostate cancer to see if combining different therapies can improve their outcomes while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 207 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Haaglanden Medical Centre Academic / other |
| Locations | 1 site (Leidschendam, South Holland) |
| Trial ID | NCT06204341 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of a comprehensive treatment approach for high risk prostate cancer by combining hypofractionated pelvic radiotherapy with a focal boost to the primary tumor and reducing androgen deprivation therapy. The study will involve men diagnosed with high risk prostate cancer who require elective lymph node irradiation. Researchers will compare oncological outcomes and toxicity levels against a matched contemporary control group. The goal is to determine if this optimized treatment can improve patient outcomes while minimizing side effects.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older diagnosed with high risk prostate cancer within the last six months.
Not a fit: Patients with prior pelvic radiotherapy or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced side effects for patients with high risk prostate cancer.
How similar studies have performed: Previous studies have shown success with individual components of this treatment approach, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leidschendam, South Holland
- Haaglanden Medical Centre — Leidschendam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Leonard P Bokhorst, MD, PhD — Haaglanden Medical Centre
- Study coordinator: Ursula J Fisscher, PhD
- Email: u.fisscher@haaglandenmc.nl
- Phone: 0031889792357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.