Clinical trial NCT05864196: Two Fraction Prostate SBRT With DIL SIB
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate Cancer,SBRT,Radiation Treatment,CyberKnife
SBRT
Radiation Treatment
CyberKnife
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
timeFrame: Up to year 5 Post-Treatment
Secondary outcomes:
measure: Nadir Prostate-Specific Antigen (nPSA) Levels
timeFrame: Up to Year 5 Post-Treatment
measure: Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
timeFrame: Baseline, Year 5 Post-Treatment
measure: Incidence of Phoenix Definition Biomechanical Failure (BCF)
timeFrame: Up to Year 5 Post-Treatment
measure: Disease-Free Survival (DFS)
timeFrame: Up to Year 5 Post-Treatment
measure: Overall Survival (OS)
timeFrame: Up to Year 5 Post-Treatment
measure: Metastasis-Free Survival (MFS)
timeFrame: Up to Year 5 Post-Treatment
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: NYCyberKnife at Perlmutter Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan Lischalk
role: PRINCIPAL_INVESTIGATOR
References: