RecruitingNot ApplicableNCT04861194
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial
Sponsor
UMC Utrecht
Enrollment
70 participants
Start Date
Jul 14, 2021
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 Years
Inclusion Criteria7
- 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 Criteria7
- 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
Interventions
RADIATIONNeurovascular-sparing
Dose reduction of the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb during 5x7.25 Gy MRgRT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04861194
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