Status:
UNKNOWN
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
Lead Sponsor:
UMC Utrecht
Conditions:
Prostate Cancer
Erectile Dysfunction Following Radiation Therapy
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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...
Detailed Description
Rationale: Erectile dysfunction is a frequent side effect of external beam radiotherapy (EBRT) for prostate cancer. To date, anatomy-based treatments that are designed to spare relevant neurovascular ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04861194
Start Date
July 14 2021
End Date
August 10 2025
Last Update
August 25 2021
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX