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New treatment option for Prostate Cancer
Official title An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
ClinicalTrials.gov ID: NCT05454488
What this study is testing
What is Focal Cryoablation?
Focal Cryoablation is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
- Phase 2: a mid-size study of how well it works
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
- English-speaking adult males
- Life expectancy over 10 years as assessed by treating physician
- Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailed below, which includes systematic biopsy cores)
- Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a single focus of disease is defined as an area seen on MRI that may be...
- Histologically confirmed adenocarcinoma of prostate
You likely can't join if
- Gleason grade group 4 or 5 disease
- Medical history or concurrent disease, which in the opinion of the investigator, poses the patient at significant peri-operative risk of complication...
- Active urinary tract infection
- Any previous treatment for prostate cancer, including radiation therapy, hormonal treatment, biologic therapy for prostate cancer, or chemotherapy
- Prior TURP or other prostate outlet procedure such as HoLEP, greenlight, microwave ablation, aquablation, UroLift, or simple prostatectomy.
- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
See the full eligibility criteria
- English-speaking adult males
- Life expectancy over 10 years as assessed by treating physician
- Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailed below, which includes systematic biopsy cores)
- Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a single focus of disease is defined as an area seen on MRI that may be biopsied multiple times using targeted biopsies and have systematic core...
- Histologically confirmed adenocarcinoma of prostate
- Organ-confined prostate cancer, clinical stage ≤T2bN0M0
- Visible tumor on MRI
- No clear evidence or high suspicion of extraprostatic extension or seminal vesical invasion on MRI
- Biopsy via transperineal or transrectal approach with at least 2 cores of MRI visible lesions that are PIRADS 2 or higher and 12 core systematic biopsy template (exclusion of cores from systematic template that overlap...
- Additional performance of microultrasound guided biopsy is allowed though not required. Please note that every effort will be made to correlate microultrasound findings with MRI, in order to determine if positive...
- Note that GGG 1 disease at sites other than ablation zone are allowed provided these are 6mm or less in size. PSA ≤15 ng/mL, or PSAD \ 15 ng/mL
- Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy
- Lesion anatomically amenable to cryotherapy treatment based on treating physician's discretion
- Willing and able to read, understand and sign the study specific informed consent document
- Willing and agreeable to comply with study protocol requirements, including focal cryotherapy ablation and all follow up visit requirements
- Patients must consent to investigative laboratory protocol (such as, but not limited to, 2021- 0560)
- Gleason grade group 4 or 5 disease
- Medical history or concurrent disease, which in the opinion of the investigator, poses the patient at significant peri-operative risk of complication due to anesthesia or the procedure
- Active urinary tract infection
- Any previous treatment for prostate cancer, including radiation therapy, hormonal treatment, biologic therapy for prostate cancer, or chemotherapy
- Prior TURP or other prostate outlet procedure such as HoLEP, greenlight, microwave ablation, aquablation, UroLift, or simple prostatectomy.
- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
- Inability to obtain prostate MRI (ex. due to claustrophobia, pacemaker, or prohibitive implants)
- Unwilling to consent to laboratory investigative protocol (such as, but not limited to, 2021- 0560)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, United States. 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.