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New treatment option for Prostate Cancer
Official title Two Fraction Prostate SBRT With DIL SIB
ClinicalTrials.gov ID: NCT05864196
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mineola, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mineola, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.