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Compares treatment options for Prostate Cancer
Official title Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
ClinicalTrials.gov ID: NCT07548164
What this study is testing
- What it's testing
- In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target; systematic biopsy pattern 4 that is...
- Gland size ≤ 80 cc
- Prostate MRI \< rT3b disease
- IPSS \< 20
- No contraindication to IRE, RT, anesthesia, or transperineal procedure
You likely can't join if
- Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma
- Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT
- Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents
- Active urinary tract infection (UTI) at the time of IRE or biopsy; must be treated and resolved prior to proceeding
- Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE...
- Any history of cardiac arrhythmia or epilepsy, or recent myocardial infarction, consistent with NanoKnife contraindication statements
See the full eligibility criteria
- Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible
- Gland size ≤ 80 cc
- Prostate MRI \< rT3b disease
- IPSS \< 20
- No contraindication to IRE, RT, anesthesia, or transperineal procedure
- Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma
- Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT
- Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents
- Active urinary tract infection (UTI) at the time of IRE or biopsy; must be treated and resolved prior to proceeding
- Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE safety
- Any history of cardiac arrhythmia or epilepsy, or recent myocardial infarction, consistent with NanoKnife contraindication statements
- Presence of an implanted pacemaker/defibrillator or other active implanted electronic device, or other device-related contraindications per current NanoKnife labeling/user manual
- Inability to undergo pelvic MRI
- Prior treatment of prostate cancer including androgen deprivation therapy, focal therapy, radiation therapy, or prostatectomy
- Current or intended use of androgen deprivation therapy
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.