Clinical trial · Interventional
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial
NCT04861194CI-TRIAL-00104677ERECTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radiation Therapy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurovascular-sparing | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neurovascular-sparing 5x7.25 Gy MRgRT
- description
- MRgRT to the prostate in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb
- interventionNames
- Radiation: Neurovascular-sparing
Primary outcomes (1)
- measure
- Erectile dysfuntion
- timeFrame
- 3 years
- description
- Erectile function score of ≤11 on the International Index of Erectile Function (IIEF) -5 questionnaire (0=worst; 25=best)
Secondary outcomes (3)
- measure
- Relapse-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRoy A, Green O, Brenneman R, Bosch W, Gay HA, Michalski JM, Baumann BC. Assessing Inter-Fraction Changes in The Size and Position of The Penile Bulb During Daily MR-Guided Radiation Therapy to The Prostate Bed: Do We Need to Adjust How We Plan Radiation in The Post-Radical Prostatectomy Setting to Reduce Risk of Erectile Dysfunction? Clin Genitourin Cancer. 2022 Jun;20(3):e227-e232. doi: 10.1016/j.clgc.2022.01.006. Epub 2022 Jan 11. PMID 35153154