Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Study Overview

• Status: Recruiting
• Conditions: Prostatic Neoplasms; Prostate Cancer; Prostate Neoplasms; Cancer of the Prostate; Prostatic Cancer
• Intervention / Treatment: Radiation: CyberKnife Stereotactic Radiosurgery

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Monahan; Phone Number: (206) 320-7129; Email: mary.monahan@swedish.org
• Study Contact Backup: Name: Robert Meier, MD; Phone Number: (206) 320-7130; Email: robert.meier@swedish.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Medical Center Radiosurgery Center
      • Contact: Robert Meier, MD; Phone Number: (206) 320-7130; Email: robert.meier@swedish.org
      • Contact: Mary Monahan; Phone Number: 206-320-7029; Email: mary.monahan@swedish.org
      • Principal Investigator: Robert Meier, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically proven prostate adenocarcinoma
• Clinical stage T1a-T3, N0-Nx, M0-Mx
• Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
• Karnofsky performance status 70-100
• Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
• Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
• High risk group: three hormone therapy regimens are allowed
• 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

• Prior prostatectomy or cryotherapy of the prostate
• Prior high-dose radiotherapy to the prostate or lower pelvis
• Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

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: CyberKnife Stereotactic Radiosurgery; This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.	Radiation: CyberKnife Stereotactic Radiosurgery; Five treatments given over about one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)	In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.	8 years
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)	In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of toxicities related to treatment	After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.	5 years
Disease free survival	Measure disease free survival after five years following cyberknife stereotactic radiosurgery.	5 years
Overall survival	Measure overall survival after five years following cyberknife stereotactic radiosurgery.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Measure quality of life after five years following cyberknife stereotactic radiosurgery.	5 years

Collaborators and Investigators

• Sponsor: Swedish Medical Center
• Investigators: Principal Investigator: Robert Meier, MD, Swedish Medical Center Radiosurgery Center

Publications and helpful links

Helpful Links

• Swedish Medical Center Radiosurgery Center

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Radiotherapy; CyberKnife; Radiation; Stereotactic Radiosurgery; Prostate Tumor; Prostate Surgery
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: IR 5642

Drug and device information, study documents

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