SBRT for Prostate Cancer

Recruiting at 1 trial location

Overseen By Vianca Santos, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: High risk disease, Pelvic lymph node involvement, Prior malignancies, 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: 4

Duration: 2 weeks

80 Participants Needed

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}

Research Team

Jonathan Lischalk

Principal Investigator

NYU Langone Health

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.

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)

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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.

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]

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]

The study compared two SBRT techniques, isocentric RapidArc (RA) and non-isocentric CyberKnife (CK), in 20 patients with localized prostate cancer, finding that RA provided better target coverage and sparing of the rectum at lower doses.

RA also demonstrated improved delivery efficiency with fewer monitor units and shorter treatment times compared to CK, making it a more favorable option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment plan comparison between stereotactic body radiation therapy techniques for prostate cancer: non-isocentric CyberKnife versus isocentric RapidArc. Lin, YW., Lin, KH., Ho, HW., et al.[2014]

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]

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 304 prostate cancer patients treated with CyberKnife stereotactic body radiotherapy (SBRT), the treatment demonstrated excellent biochemical control rates, with 97% of low-risk, 90.7% of intermediate-risk, and 74.1% of high-risk patients remaining free from biochemical recurrence at 5 years.

The treatment was associated with low toxicity, as no patients experienced severe acute complications, and only a small percentage had Grade II urinary or rectal toxicities, indicating that SBRT is a safe and effective option for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. Katz, AJ., Santoro, M., Diblasio, F., et al.[2021]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

The CyberKnife (CK) system provided significantly better dose distribution for prostate cancer treatment compared to both volumetric arc radiotherapy (VMAT) and intensity-modulated radiotherapy (IMRT), with a higher mean planning target volume dose (39.58 Gy vs. 36.25 Gy).

CK resulted in a lower mean dose to the rectum, indicating improved safety for this organ, while also achieving better conformity and homogeneity indices, although VMAT and IMRT are still considered acceptable alternatives due to their comparable performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does CyberKnife improve dose distribution versus IMRT and VMAT on a linear accelerator in low-risk prostate cancer? Borowicz, DM., Skrobała, A., Kruszyna-Mochalska, M., et al.[2023]

References

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

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

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

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

3. Australia pubmed.ncbi.nlm.nih.gov

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

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]

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

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

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

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

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

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. [2021]

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

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]

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]