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Proton Beam Therapy

CyberKnife SABR for Prostate Cancer

N/A

Recruiting

Led By Asif Harsolia, MD

Research Sponsored by MemorialCare Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior prostatectomy or cryotherapy of the prostate

No prior radiotherapy to the prostate or lower pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of CyberKnife SABR in treating prostate cancer while also monitoring for side effects.

Who is the study for?

This trial is for men with prostate cancer confirmed by biopsy within the last year. They should be in early to advanced stages (Stage I-IV, no distant metastasis), able to perform daily activities (ECOG status 0-1), and have a prostate size ≤100 cc. Prior treatments like surgery or cryotherapy on the prostate, radiotherapy to the pelvic area, or any implants that interfere with treatment are disqualifiers.

What is being tested?

The study tests CyberKnife Stereotactic Ablative Body Radiotherapy (SABR) as either a standalone treatment or an additional 'boost' therapy for prostate cancer. It aims to see how well this targeted high-dose radiation works and its impact on patients' quality of life over time.

What are the potential side effects?

Potential side effects may include skin reactions near treated areas, fatigue, urinary issues such as increased frequency or discomfort, bowel changes like diarrhea, and possibly sexual dysfunction due to the proximity of radiation to reproductive organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had surgery or cryotherapy for prostate cancer.

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I have not had radiation therapy to my prostate or lower pelvis.

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My prostate cancer was confirmed through a tissue examination.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

CyberKnife toxicities in prostate cancer

Secondary study objectives

Cancer Control

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low Risk CohortExperimental Treatment1 Intervention

The low risk cohort will receive: Stereotactic Ablative Body Radiotherapy as Monotherapy on the CyberKnife System

Group II: High Risk CohortExperimental Treatment1 Intervention

The high risk cohort will receive: 28 treatments of external beam radiation therapy followed by Stereotactic Ablative Body Radiotherapy as a Boost on the CyberKnife System and hormonal therapy as indicated.

0 / 4Eligibility criteria met