Two Fraction Prostate SBRT With DIL SIB

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864196
• Other study ID #: 22-01306
• Status: Recruiting
• Phase: Phase 1
• Start date: July 17, 2023
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Vianca Santos, MPH
• Phone: 212-496-5845
• Email: Vianca.santos[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Hospital - Long Island	Mineola	New York
United States	NYCyberKnife at Perlmutter Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Grade 2 or Higher Toxicities per CTCAE version 5.0	Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to year 5 Post-Treatment
Secondary	Nadir Prostate-Specific Antigen (nPSA) Levels	nPSA measured in ng/ml.	Up to Year 5 Post-Treatment
Secondary	Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score	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.	Baseline, Year 5 Post-Treatment
Secondary	Incidence of Phoenix Definition Biomechanical Failure (BCF)	BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).	Up to Year 5 Post-Treatment
Secondary	Disease-Free Survival (DFS)	The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.	Up to Year 5 Post-Treatment
Secondary	Overall Survival (OS)	The length of time after SBRT treatment that a patient survives.	Up to Year 5 Post-Treatment
Secondary	Metastasis-Free Survival (MFS)	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.	Up to Year 5 Post-Treatment