Preserving erectile function during prostate cancer radiation therapy

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 trial investigates the effectiveness of magnetic resonance guided adaptive radiotherapy (MRgRT) in preserving erectile function in men with low- or intermediate-risk prostate cancer. The study involves 70 participants who will receive targeted radiation treatment designed to spare critical neurovascular structures associated with erectile function. By utilizing advanced MRI technology, the trial aims to enhance treatment precision and improve post-radiotherapy erectile function outcomes. The approach is based on previous findings that suggest vascular-sparing techniques can significantly improve erectile function compared to conventional treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Histologically proven adenocarcinoma of the prostate
* Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score ≤6, and PSA \<10 µg/L; intermediate risk: T2b-T2c or Gleason score 7 or PSA 10-20 µg/L)
* Patients with pT1a/b tumor diagnosis after transurethral resection of the prostate (TURP)
* Domain score of 17-25 on the International Index of Erectile Function-5 (IIEF-5) questionnaire
* Karnofsky score of 70-100
* Written informed consent

Exclusion Criteria:

* Use of (neo-)adjuvant androgen deprivation therapy
* High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA \>20 µg/L)
* Patients with "bulky" iT3 tumor diagnosis
* Previous pelvic irradiation or radical prostatectomy
* Clinical evidence of metastatic disease
* Patients who are unable to undergo MRI
* Patients who are incompetent to sign written informed consent

Where it's running

• University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Jochem RN van der Voort van Zyp, MD PhD — UMC Utrecht
• Study coordinator: Frederik R Teunissen, MD
• Email: f.r.teunissen@umcutrecht.nl
• Phone: +31 (0)887550474

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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.