EREctile Conservation after prostate radiation Therapy (ERECT); a prospective phase 2 trial

Phase 2

Recruiting

Conditions: Erections
Prostate cancer
10038597
10018188
10036958

Registration Number: NL-OMON50019

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

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 meet exclusion criteria for MRI following the protocol of the
radiology department of the UMC Utrecht (see appendix I)
• Patients who are incompetent to sign written informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: the incidence of erectile dysfunction (ED) three years after<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: erectile dysfunction (at 6, 12 and 24 months),<br /><br>relapse-free survival, acute and late urogenital and gastrointestinal toxicity,<br /><br>and patient-reported quality of life.</p><br>