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Recruiting NCT05864196

Two Fraction Prostate SBRT With DIL SIB

Phase I Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Two-Fraction Stereotactic Body Radiation Therapy (SBRT).
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
    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.

Primary outcome measures

  • Number of Grade 2 or Higher Toxicities per CTCAE version 5.0 [Time frame: Up to year 5 Post-Treatment]
Secondary outcome measures (6)
  • Nadir Prostate-Specific Antigen (nPSA) Levels [Time frame: Up to Year 5 Post-Treatment]
  • Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score [Time frame: Baseline, Year 5 Post-Treatment]
  • Incidence of Phoenix Definition Biomechanical Failure (BCF) [Time frame: Up to Year 5 Post-Treatment]
  • Disease-Free Survival (DFS) [Time frame: Up to Year 5 Post-Treatment]
  • Overall Survival (OS) [Time frame: Up to Year 5 Post-Treatment]
  • Metastasis-Free Survival (MFS) [Time frame: Up to Year 5 Post-Treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • NYU Langone Hospital - Long Island — Mineola
  • NYCyberKnife at Perlmutter Cancer Center — New York

Identifiers

NCT: NCT05864196 · 22-01306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗