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Two Fraction Prostate SBRT With DIL SIB

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05864196
Collaborator
(none)
49
Enrollment
2
Locations
1
Arm
119
Anticipated Duration (Months)
24.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/Ib, Single Arm Study of Two Fraction SBRT With Dominant Lesion SIB for the Treatment of Low to Intermediate Risk Prostate Cancer
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2028
Anticipated Study Completion Date :
Jun 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: Men with low to intermediate risk prostate cancer

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Nadir Prostate-Specific Antigen (nPSA) Levels [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 [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) [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) [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) [Up to Year 5 Post-Treatment]

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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Hospital - Long Island Mineola New York United States 11501
2 NYCyberKnife at Perlmutter Cancer Center New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Jonathan Lischalk, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05864196
Other Study ID Numbers:
  • 22-01306
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NYU Langone Health
Prostate Cancer,SBRT,Radiation Treatment,CyberKnife
SBRT
Radiation Treatment
CyberKnife
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of May 18, 2023