Two Fraction Prostate SBRT With DIL SIB

Phase 1

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT05864196
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men with low to intermediate risk prostate cancer	Two-Fraction Stereotactic Body Radiation Therapy (SBRT)	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 Measures

Name	Time	Method
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0	Up to year 5 Post-Treatment	Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

Name	Time	Method
Metastasis-Free Survival (MFS)	Up to Year 5 Post-Treatment	The length of time after SBRT treatment that a patient is still alive and the cancer has not spread to other parts of the body.
Disease-Free Survival (DFS)	Up to Year 5 Post-Treatment	The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.
Overall Survival (OS)	Up to Year 5 Post-Treatment	The length of time after SBRT treatment that a patient survives.
Nadir Prostate-Specific Antigen (nPSA) Levels	Up to Year 5 Post-Treatment	nPSA measured in ng/ml.
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score	Baseline, Year 5 Post-Treatment	61-item assessment of quality of life in prostate cancer patients. The total score is the sum of responses and ranges from 0 to 301; higher scores indicate greater quality of life.
Incidence of Phoenix Definition Biomechanical Failure (BCF)	Up to Year 5 Post-Treatment	BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).

Trial Locations

Locations (2)

NYU Langone Hospital - Long Island; 🇺🇸 Mineola, New York, United States

NYCyberKnife at Perlmutter Cancer Center; 🇺🇸 New York, New York, United States