Preserving erectile function during prostate cancer radiation therapy
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial
NA · UMC Utrecht · NCT04861194
This study is testing a new type of radiation therapy to see if it can help men with prostate cancer keep their erectile function while receiving treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | UMC Utrecht (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT04861194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed low- or intermediate-risk prostate cancer and a specific erectile function score.
Not a fit: Patients with high-risk prostate cancer or those who have undergone previous pelvic irradiation or radical prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved erectile function preservation for prostate cancer patients undergoing radiation therapy.
How similar studies have performed: Previous studies have shown success with vascular-sparing techniques in improving erectile function outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Utrecht, Utrecht
- 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
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.
Conditions: Prostate Cancer, Erectile Dysfunction Following Radiation Therapy