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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CyberKnife toxicities in prostate cancer
Secondary outcome measures
Cancer Control

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.

Find a Location

Who is running the clinical trial?

MemorialCare Health SystemLead Sponsor
20 Previous Clinical Trials
2,388 Total Patients Enrolled
Asif Harsolia, MDPrincipal InvestigatorMemorialCare

Media Library

CyberKnife (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02016248 — N/A
Prostate Cancer Research Study Groups: Low Risk Cohort, High Risk Cohort
Prostate Cancer Clinical Trial 2023: CyberKnife Highlights & Side Effects. Trial Name: NCT02016248 — N/A
CyberKnife (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02016248 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants involved in this experiment?

"Affirmative. According to the research data available on clinicaltrials.gov, this project first posted in June 2012 and is presently recruiting participants for a total of 167 people across one location. The information was last refreshed on October 29th 2022."

Answered by AI

Is enrollment currently open for this experiment?

"Affirmative. The information located on clinicaltrials.gov demonstrates that this experiment is seeking volunteers, having been initially posted on the 1st of June 2012 and freshly edited on October 29th 2022. 167 participants will be accepted at a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer
2012. "Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02016248.
All > Prostate Cancer Anaheim
~43 spots leftby Jun 2028
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