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Radiation Therapy

Stereotactic Body Radiotherapy for Prostate Cancer

N/A
Recruiting
Led By Robert Meier, MD
Research Sponsored by Swedish Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights

Summary

This trial is studying the effects of radiation on prostate cancer patients.

Who is the study for?
Men with prostate cancer can join this trial if they have a confirmed diagnosis, are in good physical condition (Karnofsky score of 70-100), and fall into one of three risk groups based on tumor size, Gleason score, and PSA levels. Hormone therapy is allowed under specific conditions for each risk group.Check my eligibility
What is being tested?
The trial is testing the effects of CyberKnife Stereotactic Radiosurgery—a type of highly focused radiation—on prostate tumors. It aims to see if this method has fewer side effects than standard treatments and how it impacts patients' quality of life over time.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from stereotactic radiosurgery may include urinary issues, bowel problems, fatigue, skin reactions at the treatment site, erectile dysfunction, and other radiation-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in an early to mid-stage and may or may not have spread to nearby lymph nodes.
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My prostate cancer is classified as low, intermediate, or high risk.
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I am mostly able to care for myself and carry out normal activities.
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My prostate cancer was confirmed through a tissue examination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
Secondary outcome measures
Disease free survival
Overall survival
Rates of toxicities related to treatment
Other outcome measures
Quality of life

Trial Design

1Treatment groups
Experimental Treatment
Group I: CyberKnife Stereotactic RadiosurgeryExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyberKnife Stereotactic Radiosurgery
2007
N/A
~380

Find a Location

Who is running the clinical trial?

Swedish Medical CenterLead Sponsor
54 Previous Clinical Trials
8,348 Total Patients Enrolled
2 Trials studying Prostate Cancer
300 Patients Enrolled for Prostate Cancer
Robert Meier, MDPrincipal InvestigatorSwedish Medical Center Radiosurgery Center
1 Previous Clinical Trials
379 Total Patients Enrolled
1 Trials studying Prostate Cancer
379 Patients Enrolled for Prostate Cancer

Media Library

CyberKnife Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02334579 — N/A
Prostate Cancer Research Study Groups: CyberKnife Stereotactic Radiosurgery
Prostate Cancer Clinical Trial 2023: CyberKnife Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT02334579 — N/A
CyberKnife Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02334579 — N/A
~14 spots leftby Jul 2025
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