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Clinical Trial 19670

Cancer Type: Genitourinary
Interventions:Not Applicable

Study Type: Treatment
Phase of Study: Phase II

  • Peter Johnstone

Call 813-745-6100
or 1-800-679-0775

Study Title

A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer



Primary objectives The primary objectives of this study are to determine: 1)PSA disease control through 12 months after prostatectomy. 2)Symptomatic adverse anastomotic events related to pre-operative SBRT 2.2.Secondary objectives The secondary objectives of this study are to determine: 1)mean catheterization time and mean hospital stay 2)late quality of life using IPSS, and SHIM forms.

Inclusion Criteria

  • Histologically proven prostate adenocarcinoma.
  • Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
  • PSA ≤ 50 ng/ml, obtained within 3 months
  • Prostate volume: ≤60 cc.
  • IPSS score ≤15.
  • No previous radiotherapy to the prostate or lower pelvis.
  • Lymph node risk of > No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
  • No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
  • Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willing to fill out quality of life questionnaires.