Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Combining advanced treatments for high risk prostate cancer

Official title: Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour

Run by Haaglanden Medical Centre · NCT06204341 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment207 (estimated)
SponsorHaaglanden Medical Centre
Academic / other
Locations1 site (Leidschendam, South Holland)
StatusRecruiting
StartedJanuary 2, 2024
Main results expectedDecember 18, 2032
Study endsDecember 18, 2032
Registry record updatedSeptember 19, 2024
Trial IDNCT06204341 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 18 and older diagnosed with high risk prostate cancer within the last six months.

Probably not a fit

Patients with prior pelvic radiotherapy or those with metastatic disease will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown success with individual components of this treatment approach, but this specific combination is novel.

Who can join: the full rules

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 it's running

  • Haaglanden Medical Centre
    Leidschendam, South Holland, Netherlands
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.