RECRUITING

Two Fraction Prostate SBRT With DIL SIB

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Conditions

Prostate CancerProstate Cancer,SBRT,Radiation Treatment,CyberKnifeSBRTRadiation TreatmentCyberKnife

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer

Quick Facts

Study Start:2023-07-17
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05864196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age greater than or equal 18
  2. * Localized adenocarcinoma of the prostate
  3. * Biopsy-proven diagnosis of prostate adenocarcinoma
  4. * Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
  5. * TX-T2c-8th addition staging
  6. * PSA\<20 ng/ml
  7. * Grade group 3 or less
  8. * Proper rectal space replacement required as determined by the treating radiation oncologist
  9. * Prostate size less than 60cc defined at time of simulation based on MRI
  10. * Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
  11. * Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
  12. * Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
  13. * Ability to give informed consent
  1. * High risk disease
  2. * Pelvic lymph node involvement
  3. * Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
  4. * Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
  5. * Prior radiation to the pelvis
  6. * Prior malignancies within the last 5 years
  7. * Inability to meet pre-specified 2 fraction DVH constraints
  8. * Prostate size \> 60cc as measures at treatment planning MRI
  9. * Active significant inflammatory bowel disease (IBD) or rheumatological disease
  10. * Prior prostate surgeries
  11. * Previous uro lift
  12. * Transurethral resection of the prostate (TURP) within 6 months of SBRT
  13. * "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (\>50 overall summary score for each domain)
  14. * Men of reproductive potential may not participate unless they agree to use an effective contraceptive method

Contacts and Locations

Study Contact

Vianca Santos, MPH
CONTACT
212-496-5845
Vianca.santos@nyulangone.org

Principal Investigator

Jonathan Lischalk
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
NYCyberKnife at Perlmutter Cancer Center
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Jonathan Lischalk, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer,SBRT,Radiation Treatment,CyberKnife
  • SBRT
  • Radiation Treatment
  • CyberKnife

Additional Relevant MeSH Terms

  • Prostate Cancer