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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Stereotactic Body Radiation Therapy (SBRT)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Stereotactic Body Radiation Therapy (SBRT); SBRT treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Catheterization Time	Average time of catheterization following prostatectomy	Up to 4 weeks post surgery
Mean Hospital Stay	Average time of hospitalization after prostatectomy	Up to 2 week post surgery
Quality of Life assessment	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.	Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Peter Johnstone, MD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): December 4, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: radiation therapy; prostate; High Risk Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MCC-19670

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No