CyberKnife SABR for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Asif Harsolia, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MemorialCare Health System

Disqualifiers: Prior prostatectomy, Prior cryotherapy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that CyberKnife SABR for Prostate Cancer is an effective treatment?

The available research shows that CyberKnife SABR is effective for treating prostate cancer. Studies have reported positive outcomes for patients with low- and intermediate-risk prostate cancer, indicating that the treatment is both safe and feasible. Additionally, recent clinical reports have shown encouraging results for patients with locally advanced prostate cancer, suggesting that CyberKnife SABR can be a successful option for various risk levels of the disease. ^{1 2 3 4 5}

What safety data is available for CyberKnife treatment in prostate cancer?

Several studies have evaluated the safety of CyberKnife treatment for prostate cancer. These include retrospective studies on stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer, which focused on safety and feasibility. Preliminary reports and clinical trials have also assessed the safety of stereotactic ablative radiotherapy (SABR) and image-guided robotic radiosurgery with CyberKnife for various risk levels of prostate cancer. Overall, these studies suggest that CyberKnife is a safe treatment option for prostate cancer. ^{1 2 3 4 5}

Is CyberKnife a promising treatment for prostate cancer?

Yes, CyberKnife is a promising treatment for prostate cancer. It uses advanced technology to precisely target cancer cells, which can lead to effective treatment outcomes. Studies have shown encouraging results, especially for low- to intermediate-risk prostate cancer, and it is considered safe and feasible. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have not had surgery or cryotherapy for prostate cancer.

No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.

Biopsy within 12 months of date of registration

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparation

Placement of gold seeds in the prostate and planning CT and MRI scans for treatment

1-2 weeks

2 visits (in-person)

Treatment

CyberKnife stereotactic body radiotherapy delivered over 5 weekdays, with possible external beam radiation and hormonal therapy for high-risk patients

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month, 3 months, 6 months, and every 6 months thereafter for 5 years

5 years

Multiple visits (in-person)

Treatment Details

Interventions

• CyberKnife (Proton Beam Therapy)

Trial Overview 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.

Participant Groups

Group I: Low Risk Cohort Experimental Treatment 1 Intervention

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

Group II: High Risk Cohort Experimental Treatment 1 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.

CyberKnife is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

🇪🇺 Approved in European Union as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

🇨🇦 Approved in Canada as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Orange Coast Memorial Medical Center Fountain Valley, CA

Who Is Running the Clinical Trial?

MemorialCare Health System Lead Sponsor

References

1. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022] We report the results of a retrospective study of stereotactic body radiotherapy (SBRT) using a Cyberknife for prostate cancer.

2. England pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018] To describe the most recent data from phase I and II clinical trials of stereotactic body radiation therapy (SBRT) using image-guided robotic radiosurgery, specifically the Cyberknife(®) (Accuracy Incorporated, Sunnyvale, CA, USA). To better determine thecurrent role of this type of radiosurgery in prostate cancer (PCa) management.

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022] Stereotactic body radiotherapy (SBRT) takes advantage of low α/β ratio of prostate cancer to deliver a large dose in few fractions. We examined clinical outcomes of SBRT using CyberKnife for the treatment of low- and intermediate-risk prostate cancer.

4. United States pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022] We report the results of a retrospective study of stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer. The study focused on the safety and feasibility of this treatment modality.

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017] Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.