100 Participants Needed

CyberKnife SBRT for Prostate Cancer

(CK-DESPOT Trial)

Recruiting at 1 trial location
MG
RL
Overseen ByRachelle Lanciano, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Crozer-Keystone Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate cancer. Multiple single institution experiences suggest high biochemical control rates with acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.

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

The available research shows that CyberKnife SBRT is an effective treatment for prostate cancer. Studies have reported promising outcomes with minimal side effects. For example, one study highlights that CyberKnife SBRT can deliver a large dose of radiation in fewer sessions, which is beneficial for patients with low- and intermediate-risk prostate cancer. Another study compares CyberKnife to another method called Tomotherapy and suggests that CyberKnife provides favorable results. Overall, the research indicates that CyberKnife SBRT is a promising option for treating prostate cancer.12345

What data supports the effectiveness of the treatment CyberKnife SBRT for prostate cancer?

Research shows that CyberKnife SBRT for prostate cancer has promising outcomes with minimal side effects, making it a potentially effective treatment option. Studies have reported positive clinical outcomes for low- and intermediate-risk prostate cancer using this method.12345

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

Several studies have evaluated the safety of CyberKnife SBRT for prostate cancer. A retrospective study focused on the safety and feasibility of this treatment. A ten-year analysis of SBRT for low-risk prostate cancer reported on efficacy and toxicity, involving 230 patients treated with CyberKnife SBRT. Another study on low and intermediate-risk prostate cancer found that while some patients experienced acute genitourinary toxicity and proctitis, the treatment was generally safe and effective. A five-year follow-up study on older patients or those with comorbidities reported favorable survival and toxicity outcomes, with no grade 3 or higher acute complications and minimal late urinary toxicity. Overall, these studies suggest that CyberKnife SBRT is a safe treatment option for prostate cancer.56789

Is CyberKnife SBRT safe for treating prostate cancer?

Research shows that CyberKnife SBRT is generally safe for treating prostate cancer, with some patients experiencing mild to moderate side effects like urinary issues and proctitis (inflammation of the rectum). Serious side effects are rare, and most patients tolerate the treatment well.56789

Is CyberKnife SBRT a promising treatment for prostate cancer?

Yes, CyberKnife SBRT is a promising treatment for prostate cancer. It uses advanced technology to target cancer cells precisely, minimizing damage to healthy tissue. This treatment is effective for low- to intermediate-risk prostate cancer and can deliver high doses in fewer sessions, making it convenient for patients.1251011

How is CyberKnife SBRT treatment different from other prostate cancer treatments?

CyberKnife SBRT is unique because it uses a robotic system to deliver precise, high doses of radiation in fewer sessions, minimizing damage to surrounding healthy tissue. This approach, known as hypofractionation, is particularly effective for prostate cancer due to its specific biological characteristics.1251011

Research Team

RL

Rachelle Lanciano, MD

Principal Investigator

Philadelphia CyberKnife -Crozer Health

RL

Rachelle Lanciano, MD

Principal Investigator

Philadelphia CyberKnife -Crozer Health

Eligibility Criteria

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

My prostate cancer is classified as high-risk.
American Urologic Association (AUA) score < 20
I have not had a TURP procedure.
See 10 more

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.
See 3 more

Timeline

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

Treatment Details

Interventions

  • CyberKnife SBRT
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dose Escalated CyberKnife SBRTExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Crozer-Keystone Health System

Lead Sponsor

Trials
5
Recruited
290+

Findings from Research

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.
Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma.Kim, HJ., Phak, JH., Kim, WC.[2022]
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.
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]
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.
CyberKnife radiosurgery for prostate cancer.Katz, AJ.[2022]

References

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]
Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. [2018]
CyberKnife radiosurgery for prostate cancer. [2022]
Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]
Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]
Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]
Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. [2020]
Cyberknife treatment for low and intermediate risk prostate cancer. [2015]
Stereotactic body radiation therapy for prostate cancer patients with old age or medical comorbidity: a 5-year follow-up of an investigational study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. [2022]