Two Fraction Prostate SBRT With DIL SIB

NYU Langone Health

Status and phase: Enrolling; Phase 1

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05864196

22-01306

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Men with low to intermediate risk prostate cancer

Experimental group

Description:

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.

Treatment:

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