EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
Recruiting · NCT04861194 · Interventional (participants receive a specific treatment) · Lead sponsor: UMC Utrecht
View the official record on ClinicalTrials.gov →Interventions studied
Neurovascular-sparing
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University Medical Center Utrecht - Utrecht, Utrecht, Netherlands