Erectile Dysfunction (ED) Clinical Trials

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EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Frederik R Teunissen, MD
f.r.teunissen@umcutrecht.nl
+31 (0)887550474
Backup
Jochem RN van der Voort van Zyp, MD PhD
j.r.n.vandervoortvanzyp@umcutrecht.nl
Time Frame
Start Date: 2021-07-14
Estimated Completion Date: 2027-08-10
Participants
Target number of participants: 70
Treatments
Experimental: Neurovascular-sparing 5x7.25 Gy MRgRT
MRgRT to the prostate in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb
Sponsors
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov