SBRT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Jonathan Lischalk

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: High risk disease, Pelvic lymph node involvement, Prior malignancies, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist, so you may want to discuss your current medications with them.

What data supports the effectiveness of the treatment Two-Fraction Stereotactic Body Radiation Therapy (SBRT) for prostate cancer?

Research shows that SBRT, particularly using the CyberKnife system, is effective for treating low- and intermediate-risk prostate cancer by delivering high doses of radiation in fewer sessions, which is feasible and safe according to several studies. ^{1 2 3 4 5}

Is SBRT safe for treating prostate cancer?

Research shows that SBRT, including methods like CyberKnife, is generally safe for treating prostate cancer, with studies focusing on its safety and feasibility. ^{1 3 5 6 7}

How is the Two-Fraction Stereotactic Body Radiation Therapy (SBRT) treatment for prostate cancer different from other treatments?

Two-Fraction Stereotactic Body Radiation Therapy (SBRT) for prostate cancer is unique because it delivers a high dose of radiation in just a few sessions, which may be more effective due to the specific characteristics of prostate cancer cells. This approach, often using the CyberKnife system, can offer better precision and potentially improved outcomes compared to traditional radiation therapies that use lower doses over more sessions. ^{1 2 3 8 9}

Eligibility Criteria

This trial is for men over 18 with localized prostate cancer, staged TX-T2c. They must have a prostate size under 60cc, no prior malignancies within the last 5 years, and agree to use effective contraception. Excluded are those with evidence of more advanced cancer spread, large prostates over 60cc, recent prostate surgeries or treatments affecting the pelvis.

Inclusion Criteria

I am 18 years old or older.

My prostate cancer was confirmed through a biopsy.

My cancer is considered low to intermediate risk.

Exclusion Criteria

My treatment plan doesn't meet specific safety limits for radiation exposure.

"Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (>50 overall summary score for each domain)

I have had a uro lift procedure before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with a simultaneous integrated boost (SIB) for localized prostate cancer

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 visit (in-person) at 30 days post-treatment, then every 4 months for 2 years, followed by every 6 months until year 5

Treatment Details

Interventions

• Two-Fraction Stereotactic Body Radiation Therapy (SBRT) (Radiation)

Trial Overview The study tests a two-session Stereotactic Body Radiation Therapy (SBRT) targeting a dominant lesion in the prostate using MRI guidance. It's designed to see if this focused treatment is feasible and safe for patients with early-stage prostate cancer.

Participant Groups

Group I: Men with low to intermediate risk prostate cancer Experimental Treatment 1 Intervention

Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5.

Two-Fraction Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy (SBRT) for:

• Localized prostate cancer
• Early-stage lung cancer
• Liver tumors
• Pancreatic tumors
• Kidney tumors
• Metastatic tumors

🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy (SBRT) for:

• Localized prostate cancer
• Early-stage lung cancer
• Liver tumors
• Pancreatic tumors
• Kidney tumors
• Metastatic tumors

🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:

• Localized prostate cancer
• Early-stage lung cancer
• Liver tumors
• Pancreatic tumors
• Kidney tumors
• Metastatic tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYCyberKnife at Perlmutter Cancer Center New York, NY

NYU Langone Hospital - Long Island Mineola, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

References

1. 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.

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. 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.

4. Italy pubmed.ncbi.nlm.nih.gov

Treatment plan comparison between stereotactic body radiation therapy techniques for prostate cancer: non-isocentric CyberKnife versus isocentric RapidArc. [2014] The aim of this study was to evaluate the feasibility and dose distribution of two different stereotactic body radiation therapy (SBRT) techniques, isocentric RapidArc (RA) and non-isocentric CyberKnife (CK), for the treatment of localized prostate cancer.

5. 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.

6. 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.

7. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. [2021] Stereotactic body radiotherapy (SBRT) may yield disease control for prostate cancer in a brief, hypofractionated treatment regimen without increasing treatment toxicity. Our report presents a 6-year update from 304 low- (n = 211), intermediate- (n = 81), and high-risk (n = 12) prostate cancer patients who received CyberKnife SBRT.

8. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022] Stereotactic body radiation therapy (SBRT) delivers fewer high-dose fractions of radiation which may be radiobiologically favorable to conventional low-dose fractions commonly used for prostate cancer radiotherapy. We report our early experience using SBRT for localized prostate cancer.

9. Poland pubmed.ncbi.nlm.nih.gov

Does CyberKnife improve dose distribution versus IMRT and VMAT on a linear accelerator in low-risk prostate cancer? [2023] Hypofractionated stereotactic body radiation therapy (SBRT) for prostate cancer (PCa) can be delivered with the robot-assisted CyberKnife (CK) system or on a linear accelerator using dynamic intensity-modulated radiotherapy (IMRT) or volumetric arc radiotherapy (VMAT). This retrospective study was performed to determine whether CK offers better dose distribution than IMRT and/or VMAT.