EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)

Recruiting now · Not applicable

Conditions studied: Prostate Cancer, Erectile Dysfunction Following Radiation Therapy

In brief

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.

Key facts

Study ID: NCT04861194
Run by: UMC Utrecht
People needed: 70
Starts: 2021-07-14
Expected to finish: 2027-08-10
Last updated by the study team: 2026-03-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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