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Prostate CancerPhase 2POTENT-CNCT02459912

Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer

A Phase 2 study testing Unilateral Nerve-Sparing Cryoablation of the Prostate and Precise Cryoablation System with IceRod Needles in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Men with low-risk, clinically localized, unilateral prostate cancer will be treated with unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control and health related quality of life outcomes after treatment. Read more about this study

Who is it for?
Ages 40 to 69 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Unilateral Nerve-Sparing Cryoablation of the Prostate and Precise Cryoablation System with IceRod Needles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Apr 2015to 26 Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 40 to 69 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy >5 years
  • Willing and able to freely sign informed consent to enroll in the study
  • Willing to complete sexual function and HRQoL questionnaires
  • Sexually active and potent (able to achieve an EPIC questionnaire sexual domain score greater than or equal to 75 without the use of any devices or medicines to enhance erections)
  • Prostate gland volume greater than or equal to 20cc and less than or equal to 60cc
  • Does not have stress urinary incontinence defined as urinary leakage requiring the use of any protective pads
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  • Most recent serum PSA <10 ng/mL taken at least 6 weeks after a previous biopsy and 3 months +/- 2 weeks prior to study cryoablation
  • Histologically proven, clinical stage T1c-T2b prostate cancer in the proposed treated side
  • Untreated contralateral side has no malignant elements demonstrated by biopsy
  • Patient does not have ASAP (Atypical Small Acinar Proliferation) in the untreated side
  • Patient has documented, biopsy proven unilateral disease (via a minimum of 6 biopsy cores taken on the cancerous side and a minimum of 12 negative cores on the non-cancerous side) using transrectal ultrasound (TRUS) guidance
  • A 12 core biopsy using transrectal ultrasound (TRUS) guidance taken within 3 months prior to enrollment from the non-cancerous side and each core was biopsied by a site investigator
  • Biopsied areas in the non-cancerous side include the following zones: L/R (left or right side) lateral base, L/R mid gland base, L/R medial base, L/R lateral middle, L/R mid gland middle, L/R medial middle, L/R lateral apex, L/R mid gland apex, L/R medial apex, L/R transitional base, L/R transitional mid, L/R anterior horn
  • Prostate biopsy Gleason Score (GS) is less than or equal to 7. Gleason Score 3+4=7 [but not 4+3=7] is allowed as long as the score is based upon no more than 2 cores with cancer involvement of 50% or less.
  • Does not have a biopsy GS 3+4=7 combined with clinical stage T2b
  • Either a nodule was not felt (T1c) OR the palpable nodule (T2a or T2b) is on the same side as the positive biopsy

Who cannot join

  • Previous treatment for prostate cancer including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound, and/or hormone therapy
  • Previous invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA)
  • Inability to tolerate a transrectal ultrasound
  • Active urinary tract infection
  • Evidence of metastatic disease
  • Irreversible bleeding diathesis or other bleeding disorders
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  • Anatomic penile abnormalities precluding cryoablation
  • Erectile dysfunction (EPIC Questionnaire sexual domain score <60) at baseline, including the use of any erectile aid (PDE-5, etc) to increase the EPIC Questionnaire (Appendix D) sexual domain score >75, without which the patient would not qualify for the study
  • Current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study
  • Major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal, or hematological disorders, recent stroke or myocardial infarction), in the opinion of the urologist, is an illness or complication which is not consistent with the protocol requirements
  • Unwilling to undergo the necessary follow-up for the trial period
  • Bilateral prostate cancer disease
  • Significant median lobe of the prostate which would preclude an adequate cryoablation procedure (based on the discretion of the urologist)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations which would limit compliance with study requirements
  • Known HIV or AIDS-related illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU Winthrop Hospital

    Mineola, New York, 11501

Other trials in United States

About this study

Official title: Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer in Potent Men: A Prospective, Phase II Trial

Men with low-risk, clinically localized, unilateral prostate cancer will be treated with unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control and health related quality of life outcomes after treatment.

Read the detailed description

This study is a clinical trial to determine and assess the change in the rate of potency in men with low-risk, localized, unilateral prostate cancer who have not received previous treatment. A total of 86 men between 40 to 69 years of age with biopsy proven, early stage localized prostate cancer will receive unilateral nerve-sparing cryoablation. The study includes a screening/pre-operative visit, a cryoablation procedure day, and 10 follow up visits over the course of 36 months. The first follow-up visit will occur within 2 weeks (±1 week) after cryoablation. Thereafter, follow-up visits will be scheduled, from the date of procedure, every 3 months (±3 weeks) for 18 months and every 6 months (±3 weeks) thereafter until the patient completes the protocol, 36 months after the cryoablation procedure.

Conditions
Prostate Cancer
Being tested
Unilateral Nerve-Sparing Cryoablation of the Prostate, Precise Cryoablation System with IceRod Needles
Keywords
Prostate, Minimally, Low-Risk, Invasive, Cancer
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unilateral Nerve-Sparing Cryoablation of the ProstateProcedure or surgery

    The side of the prostate affected by cancer will be treated with nerve-sparing cryoablation in two freeze-thaw cycles under transrectal ultrasound guidance. The unaffected side of the prostate will not be treated.

  • Precise Cryoablation System with IceRod NeedlesDevice

    Galil Medical Precise Cryoablation System with IceRod Needles will be used for performing Unilateral Nerve-Sparing Cryoablation

Study groups in NCT02459912
Study groupRoleWhat they receive
Unilateral Nerve-Sparing CryoablationOtherUnilateral Nerve-Sparing Cryoablation of the Prostate using Galil Medical Precise Cryoablation System with IceRod Needles.
Receives: Procedure: Unilateral Nerve-Sparing Cryoablation of the Prostate; Device: Precise Cryoablation System with IceRod Needles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Potency Rate

    Determine and assess the change in the rate of potency in men with unilateral prostate cancer treated with unilateral nerve-sparing cryoablation as measured by Expended Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF-15) questionnaires

    Measured: 3 years

Secondary outcomes (9)

  1. Cancer Control in Treated Side

    Evaluate cancer control in the prostate side treated with unilateral nerve-sparing cryoablation by assessing the rate of tumor development

    Measured: 3 years

  2. Cancer Control in Untreated Side

    Assess the rate of tumor development in the contralateral (untreated) side of the prostate

    Measured: 3 years

  3. Overall Health Related Quality of Life (EPIC)

    Analyze the change in overall Health Related Quality of Life as measured by Expanded Prostate Cancer Index Composite (EPIC)

    Measured: 3 years

  4. Overall Health Related Quality of Life (SF-12)

    Analyze the change in overall Health Related Quality of Life as measured by the Short Form-12 (SF-12) Questionnaire

    Measured: 3 years

  5. Change in Urinary Continence

    Evaluate the change in Urinary Continence status compared to baseline as measured by the Urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

    Measured: 3 years

  6. Change in Voiding Function (IPSS)

    Evaluate the change in voiding function compared to baseline as measured by International Prostate Symptom Score (IPSS)

    Measured: 3 years

  7. Change in Voiding Function (Uroflow)

    Evaluate the change in voiding function compared to baseline as measured by Uroflowmetry

    Measured: 3 years

  8. Change in Voiding Function (PVR)

    Evaluate the change in voiding function compared to baseline as measured by Post-Void Residual (PVR)

    Measured: 3 years

  9. Change in Bowel Function

    Evaluate the change in bowel function compared to baseline as measured by the Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion26 Apr 2018
  4. Study completion26 Apr 2018

Why it stopped: Patient recruitment

Resources

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459912
Sponsor's protocol ID
15009
Acronym
POTENT-C
Status last verified
Feb 2019
First submitted
29 Apr 2015
Last updated
6 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Unilateral Nerve-Sparing Cryoablation of the Prostate and Precise Cryoablation System with IceRod Needles in people with Prostate Cancer, run by NYU Langone Health 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 15 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: stopped early, as of the sponsor's last update on 6 Feb 2019. 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?

The study was stopped early (reason given: Patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Potency Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459912.

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 6 Feb 2019.

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