Clinical Trial 18201

Cancer Type: Genitourinary
Interventions:Not Applicable

Study Type: Treatment
Phase of Study: Phase I

  • Peter Johnstone


Study Title

A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer


The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5, 6 or 7 Gy per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.


The primary objectives are to determine: 1) the safety of preoperative SBRT alone at 21 plus/minus 5 days post-irradiation; and 2) the dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 plus/minus 5 days and 28 plus/minus 5 days post-prostatectomy. The secondary objective is to determine whether the radiosensitivity index predicts for positive surgical margins.

Inclusion Criteria

  • Histologically-proven prostate adenocarcinoma
  • Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
  • Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
  • Patients belonging in the National Cancer Center Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA >20 ng/mL.
  • Prostate volume: ≤ 80 cc on transrectal ultrasound
  • IPSS score ≤15
  • Zubrod performance status 0-2 or equivalent
  • No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
  • No prior radiotherapy to the prostate or lower pelvis
  • 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 5 years
  • No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
  • Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
  • Age ≥18 years
  • IPSS (AUA) score ≤15

  • Exclusion Criteria

  • Does not have a diagnosis of prostate adenocarcinoma
  • Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
  • Has stage N1 or M1 (metastatic) disease
  • Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
  • Prostate volume greater than 80 cc on transrectal ultrasound
  • Zubrod performance status 3 or greater
  • Prior total prostatectomy or cryotherapy of the prostate
  • Prior radiation therapy to the pelvis
  • Implanted hardware which limits treatment planning or delivery (determined by the investigator).
  • Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
  • The use of androgen deprivation therapy (ADT) prior to registration or during radiation
  • Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
  • Unwilling or inability to give informed consent
  • Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
  • IPSS score >15
  • Age <18 years