Prostate CancerNCT07492381
A Prospective, Single-Arm, Pilot Study of the ALPFA BPH PFA System in Men With Low, Intermediate and High-Risk Prostate Cancer
A study testing ALPFA BPH PFA System in people with Prostate Cancer, run by ALPFA Medical.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ALPFA BPH PFA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2029
- Phase
- Interventional
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.
- Patients meeting prostate cancer risk categorization definitions as follows:
- Low-Risk:
- Prostate specific antigen (PSA) 4 <10 ng/mL
- Gleason score Grade Group 1 or Gleason score ≤ 6
- Clinical stage cT1c-T2a
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- Favorable Intermediate-Risk:
- PSA 10-20 ng/mL
- Gleason score 3+4 (Grade Group 2)
- Clinical stage T2b-T2c
- Less than 50% of positive biopsy cores
- Only one intermediate-risk factor present
- Unfavorable Intermediate-Risk:
- PSA 10-20 ng/mL
- Gleason score 4+3 (Grade Group 3)
- Clinical stage T2b-T2c
- More than 50% of positive biopsy cores
- High-Risk:
- Prostate specific antigen (PSA) ≥20 ng/mL
- Gleason score 8-10 (Grade Group 4-5)
- Clinical stage T3a
- Subjects with unfavorable intermediate or high-risk cancer (inclusion 2c or 2d) must be scheduled to undergo a prostatectomy between 30 days and 6 months post-Ablation Procedure.
- Biopsy confirmed adenocarcinoma of the prostate obtained up to 90 days prior to the Ablation Procedure.
- Willing and able to provide consent and comply with study requirements.
Who cannot join
- Patients with prostates previously treated with surgery (including minimally invasive), ablation, radiation therapy, chemotherapy, orchiectomy, brachytherapy, cryotherapy, or photodynamic therapy.
- Any prior radiation therapy to the pelvis
- Any evidence of metastatic disease or nodal disease outside of the prostate.
- Presence of implants/stents in the urethra
- MRI or anesthesia contraindication, including severe claustrophobia
- Bladder, genital, or other concomitant cancer within the past 5 years, except basal cell or squamous cell carcinoma of the skin.
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- Chronic or acute prostatitis, neurogenic bladder, active urinary tract infection, sphincter abnormalities, or any other symptom that impacts micturition.
- Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
- Any other condition, illness, or surgery, that in the opinion of the Investigator might confound the results of the study or pose additional risks to the patient.
- Subjects currently participating in other investigational studies unless prior approved by the Sponsor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ALPFA Medical Prostate Cancer Pilot Study
The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- ALPFA BPH PFA System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPFA BPH PFA SystemDevice
Single arm
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Device: ALPFA BPH PFA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device- or Procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure
Proportion of subjects with one or more device- or procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2029 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALPFA Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492381
- Sponsor's protocol ID
- CS-00006
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPFA Medical Prostate Cancer Pilot Study
- ClinicalTrials.gov ID
- NCT07492381
- Acronym / sponsor ID
- CS-00006
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ALPFA MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Mar 2026 (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.
The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: ALPFA BPH PFA System |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.
- Patients meeting prostate cancer risk categorization definitions as follows:
- Subjects with unfavorable intermediate or high-risk cancer (inclusion 2c or 2d) must be scheduled to undergo a prostatectomy between 30 days and 6 months post-Ablation Procedure.
- Biopsy confirmed adenocarcinoma of the prostate obtained up to 90 days prior to the Ablation Procedure.
- Willing and able to provide consent and comply with study requirements.
Key exclusion criteria (10 listed)
- Patients with prostates previously treated with surgery (including minimally invasive), ablation, radiation therapy, chemotherapy, orchiectomy, brachytherapy, cryotherapy, or photodynamic therapy.
- Any prior radiation therapy to the pelvis
- Any evidence of metastatic disease or nodal disease outside of the prostate.
- Presence of implants/stents in the urethra
- MRI or anesthesia contraindication, including severe claustrophobia
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 |
|---|---|---|
| ALPFA BPH PFA SystemSingle arm | Device | Single Arm |
Primary outcome
Device- or Procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure
Time frame: 3 months
Proportion of subjects with one or more device- or procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure
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 7 Apr 2026.
- Individual participant dataSharing planned: No. Pilot study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ALPFA BPH PFA System in people with Prostate Cancer, run by ALPFA Medical.
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 24 inclusion and 10 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Anagha Desai ((669) 257-3263, adesai@alpfamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device- or Procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure (time frame: 3 months). 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 7 Apr 2026.