Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Not Applicable

Recruiting

• Conditions: Cancer of the Prostate; Prostate Cancer; Prostatic Cancer; Prostate Neoplasms; Prostatic Neoplasms
• Interventions: Radiation: CyberKnife Stereotactic Radiosurgery

• Registration Number: NCT02334579
• Lead Sponsor: Swedish Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyberKnife Stereotactic Radiosurgery	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.

Primary Outcome Measures

Name	Time	Method
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)	8 years	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.
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)	8 years	In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Swedish Medical Center Radiosurgery Center; 🇺🇸 Seattle, Washington, United States