CyberKnife SABR for Prostate Cancer

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the CyberKnife system, a new radiation treatment for prostate cancer. The researchers aim to determine if it can precisely target tumors while minimizing damage to nearby healthy tissue, thereby improving participants' quality of life. Participants are divided into two groups: one receives only the CyberKnife treatment, while the other receives additional radiation and hormonal therapy. This trial suits those diagnosed with prostate cancer who have not undergone surgery or prior radiation treatments in the pelvic area and have completed recent diagnostic tests like a biopsy.

As an unphased trial, participants contribute to pioneering research that may lead to innovative treatment options for prostate cancer.

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 prior data suggests that the CyberKnife system is safe for treating prostate cancer?

Research has shown that CyberKnife treatment is generally safe for prostate cancer. In a study with 122 patients who had low- and intermediate-risk prostate cancer, the treatment was well-tolerated.

Other large studies have also found that patients with localized prostate cancer experienced excellent results and few harmful side effects. This suggests that CyberKnife is a safe option for many prostate cancer patients, as it delivers precise radiation to minimize damage to healthy tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CyberKnife System for prostate cancer because it offers a cutting-edge approach to radiation therapy. Unlike traditional radiation treatments that can take weeks, CyberKnife's Stereotactic Ablative Body Radiotherapy (SABR) delivers highly precise radiation in just a few sessions, minimizing damage to surrounding healthy tissue. For low-risk patients, this means a quicker, less invasive treatment option. Meanwhile, high-risk patients receive an additional boost of targeted radiation and, when necessary, hormonal therapy, potentially enhancing treatment effectiveness. This precision and efficiency make CyberKnife a promising option compared to conventional external beam radiation therapy and brachytherapy.

What evidence suggests that the CyberKnife system is effective for prostate cancer?

Studies have shown that CyberKnife, a type of precise radiation therapy, effectively treats prostate cancer. Research indicates that this treatment can control cancer well over the long term and carries a low risk of side effects, such as issues with sexual, urinary, or bowel function. In large studies, patients treated with CyberKnife experienced excellent outcomes with minimal side effects. In this trial, participants in the low-risk cohort will receive CyberKnife as monotherapy, while those in the high-risk cohort will receive external beam radiation therapy followed by CyberKnife as a boost, along with hormonal therapy as indicated. The CyberKnife system delivers high doses of radiation directly to the tumor, protecting nearby healthy tissue. This precise targeting may reduce the chance of cancer returning. ^{1 2 3 4 6}

Who Is on the Research Team?

Asif Harsolia, MD

Principal Investigator

MemorialCare

Are You a Good Fit for This Trial?

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

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

I have not had surgery or cryotherapy for prostate cancer.

Biopsy within 12 months of date of registration

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660677/

Stereotactic body radiotherapy with CyberKnife® System ... In this study, we reported our initial experience with SBRT using CyberKnife in the treatment of localized prostate cancer (the CyPro Trial). The goal of this ...

2. accuray.com accuray.com/case-studies/largest-clinical-studies-to-date-support-cyberknife-sbrt-for-localized-prostate-cancer/

Largest Clinical Studies to Date* Support CyberKnife ... Two large prospective, multi-institutional clinical studies report excellent clinical outcomes and low toxicity in localized prostate cancer patients.

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Men who received the shortened treatment, called stereotactic body radiotherapy (SBRT), did not have a higher risk of cancer recurrence over the ...

4. cyberknife.com cyberknife.com/prostate-cancer/

Prostate Cancer Key CyberKnife® treatment benefits · Excellent long-term cancer control · Significantly reduced incidence of sexual, urinary and bowel function side effects · Non- ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625034388

CyberKnife Stereotactic Body Radiation Therapy (SBRT ... Median baseline PSA was 6.5, with a median of 42% positive cores. 85% of our patients had unfavorable intermediate risk prostate cancer. The median duration of ...