Two Fraction Prostate SBRT With DIL SIB

Part of paid clinical trials in Mineola, New York.

Sponsor
NYU Langone Health
Study ID
NCT05864196
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 17, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Men with low to intermediate risk prostate cancer
    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.

Primary Outcome Measure

Number of Grade 2 or Higher Toxicities per CTCAE version 5.0 [ Time Frame: Up to year 5 Post-Treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone Hospital - Long IslandMineolaNew York11501-
NYCyberKnife at Perlmutter Cancer CenterNew YorkNew York10016-

Find similar trials in Mineola, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
NYU Langone Hospital - Long Island· Mineola, NYNYCyberKnife at Perlmutter Cancer Center· New York, NY

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