Two Fraction Prostate SBRT With DIL SIB

NCT05864196 | Recruiting Phase 1 DMC

• 1 other identifier: 22-01306
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer,SBRT,Radiation Treatment,CyberKnife; SBRT; Radiation Treatment; CyberKnife

Outcome Measures

Primary Outcomes (1)

• Number of Grade 2 or Higher Toxicities per CTCAE version 5.0

  Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  Up to year 5 Post-Treatment

Secondary Outcomes (6)

• Nadir Prostate-Specific Antigen (nPSA) Levels

  Up to Year 5 Post-Treatment

• Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score

  Baseline, Year 5 Post-Treatment

• Incidence of Phoenix Definition Biomechanical Failure (BCF)

  Up to Year 5 Post-Treatment

• Disease-Free Survival (DFS)

  Up to Year 5 Post-Treatment

• Overall Survival (OS)

  Up to Year 5 Post-Treatment

Study Arms (1)

Men with low to intermediate risk prostate cancer

EXPERIMENTAL

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.

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

Interventions

Two-Fraction Stereotactic Body Radiation Therapy (SBRT) RADIATION

Two-fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer.

Men with low to intermediate risk prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age greater than or equal 18
• Localized adenocarcinoma of the prostate
• Biopsy-proven diagnosis of prostate adenocarcinoma
• Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
• TX-T2c-8th addition staging
• PSA\<20 ng/ml
• Grade group 3 or less
• Proper rectal space replacement required as determined by the treating radiation oncologist
• Prostate size less than 60cc defined at time of simulation based on MRI
• Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
• \-- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
• Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
• Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
• Ability to give informed consent

You may not qualify if:

• High risk disease
• Pelvic lymph node involvement
• Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
• Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
• Prior radiation to the pelvis
• Prior malignancies within the last 5 years
• Inability to meet pre-specified 2 fraction DVH constraints
• Prostate size \> 60cc as measures at treatment planning MRI
• Active significant inflammatory bowel disease (IBD) or rheumatological disease
• Prior prostate surgeries
• Previous uro lift
• Transurethral resection of the prostate (TURP) within 6 months of SBRT
• "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (\>50 overall summary score for each domain)
• Men of reproductive potential may not participate unless they agree to use an effective contraceptive method

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

NYCyberKnife at Perlmutter Cancer Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Lischalk

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vianca Santos, MPH

CONTACT

212-496-5845; Vianca.santos@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Vianca.santos@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)