Comparing surgery and radiation for high-risk prostate cancer

Is this trial a fit for you?

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

What this trial studies

This observational study compares the outcomes of robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy in patients with high-risk non-metastatic prostate cancer. It aims to evaluate health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. The study addresses the lack of consensus on the optimal treatment approach for this patient population, providing insights that could inform clinical guidelines and shared decision-making. By analyzing data from multiple hospitals, the study seeks to clarify treatment effectiveness and patient preferences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed de novo non-metastatic high-risk prostate cancer.
* cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
* International Society of Urological Pathology (ISUP) grade ≥4 and/or
* Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
* Fit for treatment with either RARP or EBRT +/- ADT (WHO performance status 0-1)
* Living in the Netherlands
* Able to read and understand the Dutch language

Exclusion Criteria:

* Histological types other than adenocarcinoma
* Diagnosis and/or treatment in a hospital abroad
* Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan

Where it's running

• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Antoni van Leeuwenhoek Ziekenhuis
  Amsterdam, Netherlands Recruiting
• BovenIJ ziekenhuis
  Amsterdam, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Recruiting
• Wilhelmina Ziekenhuis
  Assen, Netherlands Recruiting

Study contacts

• Principal investigator: Katja Aben, PhD — Comprehensive Cancer Centre The Netherlands
• Study coordinator: Berdine Heesterman, MD, PhD
• Email: b.heesterman@iknl.nl
• Phone: 316 39 27 71 73

Similar studies

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

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• Lower-dose radiation to parts of the prostate for some men with prostate cancer

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

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  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

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• Two-fraction radiotherapy for localized prostate cancer

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  Recruiting UMC Utrecht · Utrecht · NCT06518226

• Radiation therapy for recurrent prostate cancer

  This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06392295

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.