Virtual HDR Cyberknife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

Trial ID:
IRB-12-5894
Donald Fuller
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
  • Karnofsky performance status > 80.
  • Patient must be ≥ 18 years of age.
    • Gleason Sum < or = 7
    • Prostate-specific antigen < or = 20 ng/ml
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
  • Gleason Score > 7.
  • PSA > 20 ng/ml.
  • Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
  • History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
  • Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
  • Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
  • Metallic Hip prosthesis.
  • History of inflammatory bowel disease

Contact Info:

  • Carlyn A Tripp
  • ctripp@genhp.com
  • 619-230-0400