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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for men with localized prostate cancer. The treatment involves Two-Fraction Stereotactic Body Radiation Therapy (SBRT), which uses focused radiation to target cancer cells in just two sessions. The main goal is to determine the safety and effectiveness of this method. Men diagnosed with low to intermediate risk prostate cancer who have not received prior pelvic radiation might be suitable candidates for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that Two-Fraction Stereotactic Body Radiation Therapy (SBRT) is safe for treating localized prostate cancer?

Research has shown that Two-Fraction Stereotactic Body Radiation Therapy (SBRT) is safe for treating prostate cancer. Studies indicate that this treatment results in low rates of serious side effects. In one study, patients experienced similar outcomes to those receiving another type of radiation therapy, without an increase in negative reactions. Another study found that SBRT had low rates of severe side effects in patients with low or intermediate-risk prostate cancer. These findings suggest that the treatment is well-tolerated and has a strong safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Two-Fraction Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a faster treatment alternative compared to traditional radiation therapies, which usually require multiple sessions over several weeks. SBRT delivers highly precise doses of radiation in just two sessions, potentially reducing the overall treatment burden on patients. Additionally, the precision of SBRT aims to minimize damage to surrounding healthy tissues, which is a significant concern with conventional radiation therapies. This approach not only promises convenience but also potentially fewer side effects, making it an appealing option for patients with low to intermediate-risk prostate cancer.

What evidence suggests that Two-Fraction SBRT might be an effective treatment for prostate cancer?

Research has shown that Two-Fraction Stereotactic Body Radiation Therapy (SBRT), which participants in this trial will receive, could be promising for treating localized prostate cancer. Studies have found that two-fraction SBRT controls cancer as effectively and has side effects similar to another treatment known as HDR brachytherapy. This suggests it might be equally effective at preventing cancer recurrence. Additionally, SBRT has successfully treated patients with low- and intermediate-risk prostate cancer, providing good long-term results. These findings suggest that Two-Fraction SBRT could be an effective treatment option for localized prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Jonathan Lischalk

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

My prostate cancer was confirmed through a biopsy.

My cancer is considered low to intermediate risk.

Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402200086X

Two-fraction stereotactic ablative radiotherapy (SABR ... Two-fraction SABR yields similar rates of biochemical failure, acute and late toxicities, and QOL as two-faction HDR brachytherapy.

2. 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 ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)00086-X/abstract

Two-fraction stereotactic ablative radiotherapy (SABR ... Two-fraction SABR yields similar rates of biochemical failure, acute and late toxicities, and QOL as two-faction HDR brachytherapy. These data ...

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06027892

Study Details | NCT06027892 | Two-fraction Versus Five- ... The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6484596/

Long-term Outcomes of Stereotactic Body Radiotherapy for ... In this study, stereotactic body radiotherapy for low-risk and intermediate-risk disease was associated with low rates of severe toxic events ...

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

and intermediate-risk prostate cancer: clinical outcomes ... Conclusion: Our study confirms that SBRT of 35–36.25 Gy in five fractions with the CyberKnife System produces excellent control with low toxicity in patients ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12165-1

SABR-Dual: a phase II/III trial of two-fraction versus five ... This study aims to evaluate the safety, efficacy, and non-inferiority of generalizable 2-fraction SABR compared to the current 5-fraction regimen.