RightFit
RecruitingPhase 3

Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer

Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two extra treatments, called boosts, for people with intermediate-risk prostate cancer. It tests whether irreversible electroporation (IRE), which uses electrical pulses, works as well as a radiation boost. Everyone receives standard stereotactic body radiotherapy (SBRT), a focused type of radiation treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A biopsy shows grade group 2 or 3 prostate cancer. All pattern 4 cancer, a faster-growing type, must match the area seen on MRI, as judged by the study doctor.
  • The prostate is no larger than 80 cubic centimeters.
  • MRI shows cancer below stage rT3b, meaning it has not reached the nearby sacs that make semen or gone beyond them.
  • Your urinary symptom score (IPSS) is below 20.
  • You can safely have IRE, radiation, anesthesia, and a procedure through the skin between the scrotum and anus.

Who can't join

  • Cancer is grade group 4 or higher, or has cribriform or intraductal features—certain cancer growth patterns.
  • MRI or PSMA PET/CT scans show cancer in lymph nodes or other parts of the body.
  • You cannot safely have general anesthesia, which puts you to sleep, or the required muscle-relaxing drugs.
  • You have a urinary tract infection when IRE or biopsy is planned. It must be treated and cleared first.
  • You are bleeding, have a known bleeding disorder, or cannot safely pause blood-thinning medicines for biopsy or IRE.
  • You have a history of abnormal heart rhythms or epilepsy, a recent heart attack, an implanted electronic device such as a pacemaker, or another condition barred by the NanoKnife device safety rules.
  • You cannot have an MRI of the pelvis.
  • You have had prostate cancer treatment, including hormone-lowering treatment, treatment aimed at one area, radiation, or prostate removal. Current or planned hormone-lowering treatment also rules you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Study sites (8)

NJ

NY