NCT04861194 EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
| NCT ID | NCT04861194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-07-14 |
| Primary Completion | 2027-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2021-07-14 with a primary completion date of 2027-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Single-arm phase II trial of 70 men with low- or intermediate-risk prostate cancer receiving magnetic resonance guided adaptive radiotherapy (MRgRT) in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, the internal pudendal arteries, the corpora cavernosa, and the penile bulb for erectile function preservation.
Eligibility 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
Contact & Investigator
Jochem RN van der Voort van Zyp, MD PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT04861194 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04861194 currently recruiting?
Yes, NCT04861194 is actively recruiting participants. Contact the research team at f.r.teunissen@umcutrecht.nl for enrollment information.
Where is the NCT04861194 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT04861194 clinical trial?
NCT04861194 is sponsored by UMC Utrecht. The principal investigator is Jochem RN van der Voort van Zyp, MD PhD at UMC Utrecht. The trial plans to enroll 70 participants.
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