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NCT Number: NCT05864196

Two Fraction Prostate SBRT With DIL SIB

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Grade 2 or Higher Toxicities per CTCAE version 5.0

    Time frame: 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 outcomes

  1. Nadir Prostate-Specific Antigen (nPSA) Levels

    Time frame: Up to Year 5 Post-Treatment

    nPSA measured in ng/ml.

  2. Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score

    Time frame: 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.

  3. Incidence of Phoenix Definition Biomechanical Failure (BCF)

    Time frame: Up to Year 5 Post-Treatment

    BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).

  4. Disease-Free Survival (DFS)

    Time frame: Up to Year 5 Post-Treatment

    The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.

  5. Overall Survival (OS)

    Time frame: Up to Year 5 Post-Treatment

    The length of time after SBRT treatment that a patient survives.

  6. Metastasis-Free Survival (MFS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vianca Santos, MPH

CONTACT

[email protected]

212-496-5845

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
May 18, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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