CyberKnife SABR for Prostate Cancer

Overseen By Kristina Go-Alejo

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: MemorialCare Health System

Disqualifiers: Prior prostatectomy, Prior cryotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1-2 weeks

167 Participants Needed

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}

Research Team

Asif Harsolia, MD

Principal Investigator

MemorialCare

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

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

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

Who Is Running the Clinical Trial?

MemorialCare Health System

Lead Sponsor

Trials

21

Recruited

2,600+

Findings from Research

In a study of 29 prostate cancer patients treated with stereotactic body radiotherapy (SBRT) using a Cyberknife, PSA levels showed a significant decrease over time, with a median nadir of 0.329 ng/mL achieved after 23 months.

The treatment demonstrated a favorable safety profile, with only 3% of patients experiencing Grade 2 urinary toxicities and no severe late rectal toxicities reported, indicating that SBRT is a feasible option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. Lee, YH., Son, SH., Yoon, SC., et al.[2022]

The Cyberknife® system, used for stereotactic body radiation therapy (SBRT), shows promising efficacy in treating localized prostate cancer, with median PSA levels dropping significantly after treatment and biochemical progression-free survival rates ranging from 78.3% to 100% over a follow-up period of 4 to 60 months.

While the treatment is associated with mostly mild side effects (grade 1/2), there are reports of erectile dysfunction and some grade 3 toxicities, indicating a need for further long-term studies and randomized trials to establish its safety and effectiveness as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. Seisen, T., Drouin, SJ., Phé, V., et al.[2018]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

In a study of 33 patients with low- and intermediate-risk prostate cancer treated with CyberKnife SBRT, there was no biochemical failure, indicating high efficacy of the treatment over a median follow-up of 51 months.

The treatment resulted in manageable side effects, with no grade 3 acute or late toxicities reported, and most acute complications resolved within 2 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. Kim, HJ., Phak, JH., Kim, WC.[2022]

References

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

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]

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

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

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

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]