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

Overview

This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 15, 2019

Interventions

  • Device: Stereotactic Body Radiation Therapy (SBRT)
    • SBRT treatment

Arms, Groups and Cohorts

  • Experimental: Stereotactic Body Radiation Therapy, followed by Prostatectomy
    • Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Measure of PSA (Prostate Specific Antigen)
    • Time Frame: Up to 12 months
    • Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
  • Number of symptomatic adverse anastomotic events
    • Time Frame: Up to 12 months
    • Number of symptomatic anastomotic events related to pre-operative SBRT.

Secondary Measures

  • Mean Catheterization Time
    • Time Frame: Up to 4 weeks post surgery
    • Average time of catheterization following prostatectomy
  • Mean Hospital Stay
    • Time Frame: Up to 2 week post surgery
    • Average time of hospitalization after prostatectomy
  • Quality of Life assessment
    • Time Frame: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
    • Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 “not at all” to 5 “always”. The SHIM is a five question questionnaire ranging from 1 “almost never or never” to 5 “almost always or always” to determine erectile dysfunction.

Participating in This Clinical Trial

  • 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 <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
  • 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.
  • Gender Eligibility: Male

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • H. Lee Moffitt Cancer Center and Research Institute
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Peter Johnstone, MD, Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute

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