CyberKnife SBRT for Prostate Cancer

(CK-DESPOT Trial)

Not currently recruiting at 1 trial location

Overseen By Rachelle Lanciano, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Crozer-Keystone Health System

Disqualifiers: Other cancers, Prostate size, AUA score, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called CyberKnife SBRT, a precise, high-dose radiation therapy for prostate cancer. The goal is to determine if this method effectively treats more challenging cases of prostate cancer while minimizing damage to surrounding healthy tissue. Suitable candidates for this trial have received a prostate cancer diagnosis within the last year and have not undergone previous radiation or surgery on the prostate.

As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not have any medical or psychiatric illnesses that would interfere with treatment or follow-up, which might imply some medication adjustments. Please consult with the trial coordinators for specific guidance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CyberKnife SBRT is safe for treating prostate cancer?

A previous study demonstrated that CyberKnife Stereotactic Body Radiation Therapy (SBRT) is a safe option with few harmful side effects for men with prostate cancer. Research indicates that SBRT provides good results with manageable side effects. For instance, a large study reported low levels of toxicity, meaning it caused few harmful side effects. Another study found that SBRT effectively controlled prostate cancer and had tolerable side effects, particularly for patients with a Gleason score under 8.

However, some side effects were reported. Over five years, 27% of men who received SBRT experienced urinary issues, compared to 18% who received standard radiation therapy. Despite this, many studies have shown that the treatment is generally well-tolerated. Research supports its use as a promising option for treating localized prostate cancer, achieving effective results while sparing normal tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CyberKnife SBRT for prostate cancer because it offers a highly precise and non-invasive treatment option. Unlike traditional radiation therapy, which can take several weeks, CyberKnife delivers high doses of radiation in just five sessions over 7-10 days. This treatment uses a robotic system to target tumors with pinpoint accuracy, minimizing radiation exposure to surrounding healthy tissue. This precision reduces potential side effects and may improve the overall effectiveness of the treatment.

What evidence suggests that CyberKnife SBRT is effective for prostate cancer?

Research shows that CyberKnife SBRT effectively treats certain prostate cancers. Studies have found that this treatment can achieve a high five-year cure rate of up to 98% for prostate cancer that hasn't spread. In one study, patients with low- and intermediate-risk prostate cancer treated with CyberKnife SBRT had excellent results and experienced few side effects. Another study found that SBRT offers a five-year rate of 83.6% for preventing cancer progression. These findings suggest that CyberKnife SBRT can effectively control prostate cancer while reducing harm to healthy tissue.

In this trial, participants will receive Dose Escalated CyberKnife SBRT, which involves five SBRT treatments delivered using the CyberKnife robotic radiosurgery system. ^{2 3 4 6 7}

Who Is on the Research Team?

Rachelle Lanciano, MD

Principal Investigator

Philadelphia CyberKnife -Crozer Health

Rachelle Lanciano, MD

Principal Investigator

Philadelphia CyberKnife -Crozer Health

Are You a Good Fit for This Trial?

Men with a specific type of prostate cancer that hasn't spread, diagnosed within the last year. They should have a prostate size less than 100 cc, low urinary symptoms (AUA score <20), and no prior major prostate surgeries or pelvic radiation. Men who've had other cancers besides non-melanoma skin cancer in the past 5 years or those with implanted hardware near the prostate are not eligible.

Inclusion Criteria

American Urologic Association (AUA) score < 20

My prostate cancer is classified as high-risk.

I have not had a TURP procedure.

Exclusion Criteria

I cannot take hormone therapy due to health reasons.

AUA greater than 20

You have metal devices in your body that could interfere with the imaging tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CyberKnife-SBRT with an escalated dose of 40 Gy in 5 fractions over 7-10 days

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and toxicity

24 months

What Are the Treatments Tested in This Trial?

Interventions

• CyberKnife SBRT

Trial Overview The trial is testing CyberKnife SBRT, an advanced form of targeted radiation therapy designed to increase dosage accuracy for treating unfavorable types of localized prostate cancer while minimizing damage to surrounding healthy tissue.

How Is the Trial Designed?

Group I: Dose Escalated CyberKnife SBRT Experimental Treatment 1 Intervention

DE-SBRT will be delivered using the CyberKnife robotic radiosurgery system. Patients will be treated with five SBRT treatments (8 Gy per fraction to the PTV, and 9-10 Gy per fraction to any nodules identified on endorectal MRI) over 7-10 days.

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

Approved in United States as CyberKnife SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer

Approved in European Union as CyberKnife SBRT for:

• Localized prostate cancer
• Early-stage prostate cancer

Approved in Canada as CyberKnife SBRT for:

• Prostate cancer
• Localized prostate cancer

Approved in United Kingdom as CyberKnife SBRT for:

• Intermediate-risk prostate cancer
• High-risk prostate cancer

Who Is Running the Clinical Trial?

Crozer-Keystone Health System

Lead Sponsor

Trials

5

Recruited

290+

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]

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]

Recent data indicate that CyberKnife SBRT (Stereotactic Body Radiation Therapy) for prostate cancer shows promising treatment outcomes with minimal toxicity, suggesting it could be a safe and effective option.

Despite ongoing controversy in the radiation oncology community, the radiobiologic characteristics of the prostate make it a strong candidate for SBRT, highlighting the need for further evaluation and acceptance of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife radiosurgery for prostate cancer. Katz, AJ.[2022]

The CyberKnife (CK) technique for treating low- to intermediate-risk prostate cancer showed excellent dose delivery, with 95.8% of the prostate receiving the prescribed radiation dose, indicating effective targeting of the tumor while minimizing exposure to surrounding tissues.

Patients tolerated the CK monotherapy well, with stable urinary symptoms and mild bowel symptoms reported after treatment, suggesting a favorable safety profile during the initial follow-up period of 5.1 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. Aluwini, S., van Rooij, P., Hoogeman, M., et al.[2016]

In a study of 45 prostate cancer patients treated with stereotactic body radiation therapy (SBRT) using Cyberknife, the 5-year biochemical relapse-free survival (bRFS) rate was high at 89.7%, indicating effective long-term control of the disease.

The treatment was found to be safe, with no severe acute complications and only 4.4% of patients experiencing grade 3 or higher late urinary toxicity, suggesting that SBRT is a viable option for older patients or those with medical comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer patients with old age or medical comorbidity: a 5-year follow-up of an investigational study. Lee, SW., Jang, HS., Lee, JH., et al.[2022]

CyberKnife (CK) stereotactic body radiotherapy (SBRT) can effectively replicate the dose and distribution of high-dose-rate (HDR) brachytherapy for prostate cancer, with similar planning target volume coverage and improved urethra dose sparing in 9 out of 10 patients.

Early clinical results show a significant reduction in prostate-specific antigen levels (86% decrease from baseline) after CK SBRT, with minimal and transient acute toxicity, primarily urologic, indicating a promising safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. Fuller, DB., Naitoh, J., Lee, C., et al.[2022]

In a study of 230 men with early low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), the ten-year biochemical disease-free survival rate was an impressive 93%, indicating high efficacy of this treatment.

The treatment showed low toxicity, with only 10% of patients experiencing mild late urinary toxicity and 4% with late rectal toxicity, while quality of life scores for bowel and urinary function returned to baseline after initial declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. Katz, A.[2020]

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]

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 involving 32 patients with early-stage prostate cancer treated with Cyberknife, 29 patients remained free of disease at the last follow-up, indicating strong efficacy of this treatment.

While some patients experienced mild to moderate side effects, including acute genitourinary toxicity and proctitis, all patients were alive at the last follow-up, suggesting that Cyberknife is a safe option for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife treatment for low and intermediate risk prostate cancer. Detti, B., Bonomo, P., Masi, L., et al.[2015]

In a study of 12 localized prostate cancer cases, Tomotherapy (HT) demonstrated superior dosimetric results compared to Cyberknife (CK), achieving better dose homogeneity, target coverage, and conformity, which are crucial for effective treatment.

HT also predicted lower late rectal toxicity and resulted in a significantly lower integral dose to the body, suggesting that it may offer clinical benefits by reducing the risk of side effects associated with radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. Chen, CY., Lee, LM., Yu, HW., et al.[2018]

Citations

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

Stereotactic body radiotherapy with CyberKnife® System ... A total of 122 patients with low- and intermediate-risk prostate cancer were treated with the CyberKnife System at a dose of 35 Gy or 36.25 Gy in five fractions ...

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

SBRT Proves Effective for Some Prostate Cancers - NCI But it had to be confirmed that a 5-day course of SBRT was not worse at controlling cancer than standard radiation therapy and also that it does ...

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... The study investigated the efficacy and toxicity of SBRT for localized PCa. Overall, SBRT may offer a higher 5-year bPFS rate of 83.6% and effective symptom ...

5. oklahomacyberknife.com oklahomacyberknife.com/resources/stereotactic-body-radiation-therapy-shows-98-percent-prostate-cancer-cure-rate/

SBRT Shows 98% Prostate Cancer Cure Rate A five-year study shows that stereotactic body radiation therapy (SBRT) offers a higher cure rate for prostate cancer than more traditional approaches.

6. redjournal.org redjournal.org/article/S0360-3016(25)03438-8/fulltext

CyberKnife Stereotactic Body Radiation Therapy (SBRT ... This study describes a novel, safe, and low-toxicity radiation protocol for men with intermediate and high-risk prostate cancer, demonstrating that simultaneous ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1270498/full

and intermediate-risk prostate cancer: clinical outcomes ... Results: The 1-, 2-, and 5-year DFS rates were 92.9%, 92.9%, and 92.3%, respectively, while the 1-, 2-, and 5-year bDFS rates were 100%, 100%, and 95.7%, ...