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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Disease free survival

Overall survival

Rates of toxicities related to treatment

Other study objectives

Quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met