Recruiting

Stereotactic Body Radiotherapy

Sponsor:

Swedish Medical Center

Code:

NCT02334579

Conditions

Prostate Cancer

Prostatic Cancer

Prostate Neoplasms

Prostatic Neoplasms

Cancer of the Prostate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CyberKnife Stereotactic Radiosurgery

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Prostatic Cancer

Prostate Neoplasms

Prostatic Neoplasms

Cancer of the Prostate

Study ID

NCT02334579

Start date

Dec, 2014

Status verified date

Jul, 2019

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

146 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

CyberKnife Stereotactic Radiosurgery

Five treatments given over about one week.

Primary outcome measure

  • Quality of life outcomes (low- and intermediate-risk prostate cancer groups) [ Time Frame: 8 years ]
  • Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group) [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

Mary Monahan

(206) 320-7129mary.monahan@swedish.org

Robert Meier, MD

(206) 320-7130robert.meier@swedish.org

Locations

Swedish Medical Center Radiosurgery Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Mary Monahan

206-320-7029mary.monahan@swedish.org

Robert Meier, MD

(206) 320-7130robert.meier@swedish.org

Principal Investigator:

Robert Meier, MD

More Information

Sponsor

Swedish Medical Center

Last update posted

Jul 12, 2019

Last verified

Jul, 2019

Keywords

  • Radiation
  • Stereotactic Radiosurgery
  • Radiotherapy
  • Prostate Tumor
  • Prostate Surgery
  • CyberKnife

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2019-07-12.