Two Fraction Prostate SBRT With DIL SIB

Trial Title: Two Fraction Prostate SBRT With DIL SIB

NCT ID: NCT05864196

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate Cancer,SBRT,Radiation Treatment,CyberKnife
SBRT
Radiation Treatment
CyberKnife

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Description: 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.
Arm group label: Men with low to intermediate risk prostate cancer

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NYU Langone Hospital - Long Island

Address:
City: Mineola
Zip: 11501
Country: United States

Status: Recruiting

Facility:
Name: NYCyberKnife at Perlmutter Cancer Center

Address:
City: New York
Zip: 10016
Country: United States

Status: Recruiting

Start date: July 17, 2023

Completion date: June 2026

Lead sponsor:
Agency: NYU Langone Health
Agency class: Other

Source: NYU Langone Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05864196