EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)

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

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

Conditions3

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