Prostate CancerPhase 2NCT05454488
An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
A Phase 2 study testing Focal Cryoablation and Quality-of-life Questionnaires in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Cryoablation and Quality-of-life Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 biopsies directly adjacent to targeted cores; all of which being considered as from the same focus)
- Histologically confirmed adenocarcinoma of prostate
- Organ-confined prostate cancer, clinical stage ≤T2bN0M0
Show all 16Show fewer
- 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 with targeted cores allowed).
- 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 results are from the same MRIvisible focus. This determination will be made by the surgeon performing the biopsy.
- 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 <0.15 if PSA >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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Justin Gregg, MD, 713-792-3250, jrgregg@mdanderson.org
Justin Gregg, MD
About this study
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
Read the detailed description
Primary Objective:
- To determine the effectiveness of an evidence-based focal cryotherapy ablation by measuring negative in-field recurrence rate at 6-months post-ablation.
Secondary Objectives:
- To determine quality of life following focal prostate cancer ablation using validated questionnaires (EPIC-26, AUA symptoms score, SHIM).
- To establish PSA kinetics post-evidence-based focal cryotherapy ablation.
- To determine rates of out of field recurrence on 6-month biopsy following focal cryotherapy ablation.
- To determine MRI findings post-focal cryotherapy ablation, including those related to prostate and surrounding periprostatic fat volume.
- To determine rate of progression and re-intervention collected as part of standard of care treatment for 5-year following study treatment.
- To describe financial toxicity associated with focal prostate cancer treatment using cryotherapy.
- To describe the incidence and severity of complications within 30-days after the study focal ablation treatment.
- To describe imaging findings on PSMA PET MRI performed in a subset of men after standard of care focal cryotherapy prior to 6-month biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Focal Cryoablation, Standard of Care, Quality-of-life Questionnaires
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal CryoablationDrug
Participants will have the Focal cryoablation placed by the needles in such a way that the area of affected tissue is much smaller and focus just on the tumor tissue and surrounding area
Standard of CareOther
Participants will receive a prostate biopsy.
Quality-of-life QuestionnairesOther
Participants will fill out questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Focal therapy Treatment | Experimental | Cryoablation is a procedure in which special needles are inserted into the tumor site. Receives: Drug: Focal Cryoablation; Other: Standard of Care; Other: Quality-of-life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-life Questionnaires
Score scale ranges (0-5) 0-Not at all/5- Almost always
Measured: through completion an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start25 Jul 2022
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Gregg, MD, Principal investigator, jrgregg@mdanderson.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454488
- Sponsor's protocol ID
- 2022-0165
- Other IDs
- NCI-2022-05462
- Status last verified
- May 2026
- First submitted
- 28 Jun 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05454488
- Acronym / sponsor ID
- 2022-0165
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
Detailed description
Primary Objective:
- To determine the effectiveness of an evidence-based focal cryotherapy ablation by measuring negative in-field recurrence rate at 6-months post-ablation.
Secondary Objectives:
- To determine quality of life following focal prostate cancer ablation using validated questionnaires (EPIC-26, AUA symptoms score, SHIM).
- To establish PSA kinetics post-evidence-based focal cryotherapy ablation.
- To determine rates of out of field recurrence on 6-month biopsy following focal cryotherapy ablation.
- To determine MRI findings post-focal cryotherapy ablation, including those related to prostate and surrounding periprostatic fat volume.
- To determine rate of progression and re-intervention collected as part of standard of care treatment for 5-year following study treatment.
- To describe financial toxicity associated with focal prostate cancer treatment using cryotherapy.
- To describe the incidence and severity of complications within 30-days after the study focal ablation treatment.
- To describe imaging findings on PSMA PET MRI performed in a subset of men after standard of care focal cryotherapy prior to 6-month biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal therapy Treatment | Experimental | Drug: Focal Cryoablation, Other: Standard of Care, Other: Quality-of-life QuestionnairesCryoablation is a procedure in which special needles are inserted into the tumor site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 biopsies directly adjacent to targeted cores; all of which being considered as from the same focus)
- Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal CryoablationParticipants will have the Focal cryoablation placed by the needles in such a way that the area of affected tissue is much smaller and focus just on the tumor tissue and surrounding area | Drug | Focal therapy Treatment |
| Standard of CareParticipants will receive a prostate biopsy. | Other | Focal therapy Treatment |
| Quality-of-life QuestionnairesParticipants will fill out questionnaires. | Other | Focal therapy Treatment |
Primary outcome
Quality-of-life Questionnaires
Time frame: through completion an average of 1 year.
Score scale ranges (0-5) 0-Not at all/5- Almost always
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Gregg, MD principal investigator
jrgregg@mdanderson.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Focal Cryoablation and Quality-of-life Questionnaires in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Gregg, MD (713-792-3250, jrgregg@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-of-life Questionnaires (time frame: through completion an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.