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POTEN-C Trial

The POTEN-C Trial (Prostate Oncologic Therapy Ensuring Neurovascular Conservation) is a phase II randomized multi-center trial that will evaluate whether two-year sexual quality of life (measured by the EPIC battery sexual domain) will be improved by a dose-painted sparing of neurovascular elements technique aided by use of rectal SpaceOAR™ during SAbR.

A phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) and rectal SpaceOAR with or without neurovascular sparing for erectile function preservation in localized prostate cancer. a study of prostate oncologic therapy while ensuring neurovascular conservation (SAbR POTEN-C)

  1. Eligibility

    • Low/Intermediate risk PCa (exclude if all intermediate risk factors present*)
    • No androgen deprivation therapy
    • Baseline erectile potency by EPIC sexual domain 60-100
    • No lesion within 5mm of one neurovascular bundle by MRI

  2. Registration

    • Rectal SpaceOar and fiducials
    • Labs
    • EPIC baseline
    • CT/MR*** simulation and delineation of neurovascular structures for sparing in all pt

  3. Stratify

    • EPIC sexual domain score ≥80 vs. 60-79
    • Institution
    • Baseline sexual aid or medication use

  4. Randomize (Dose 40-45 Gy/5 fractions)

    • Neurovascular sparing SAbR with dose-painting approach
    • Standard SAbR

  5. Endpoints

    • Primary endpoint/stats:
      • Two-year decline in EPIC sexual domain
      • N=120 pts
      • 15% attrition, stdev 20, effect size 0.50, alpha 0.1
    • Secondary endpoints:
      • Biochemical failure, DMFS, CSS
      • Other HRQOL EPIC domains
      • Comparison of both arms vs. historic SBRT prostate control without rectal spacer

*cT2b-cT2c, Gleason 7, >50% cores involved, PSA>10 
**internal pudendal artery, neurovascular bundle, penile bulb
***Recommend CT with UV contrast push to simulate arteriogram 

POTEN-C Trial Team

PI: Neil B. Desai, M.D., UT Southwestern Medical Center
Physics: Yulong Yan, Ph.D., UT Southwestern Medical Center

The POTEN-C group would like to acknowledge support from Boston Scientific. The program is administered by the Department of Radiation Oncology at UT Southwestern Medical Center.

  • Rectal SpaceOar & fiducials
  • Labs
  • EPIC baseline score
  • CT/MR*
  • Simulation and delineation of neurovascular structures for sparing in all pt
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