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Trial record 5 of 27 for:    Peyronies disease

Treatment Response to Xiaflex for Men With Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT03774264
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

Brief Summary:

Xiaflex, Collagenase Clostridium histolyticum (CCH) is the only FDA approved medical treatment for correcting penile curvature associated with Peyronie's disease. Xiaflex is efficacious in approximately 60% of patients with an average improvement in penile curvature of 17 degrees as defined by global response assessment.

Previous analysis indicate that men who were more likely to demonstrate a greater response to Xiaflex were those men with: 1) penile curvature 30-60°; 2) disease duration >4 years; 3) no plaque calcifications; and 4) IIEF score 1-5 (no sexual activity) and ≥17.

Current evaluation of Peyronie's Disease at the University of Miami incorporates the use of penile duplex ultrasound following administration of intracavernosal vasoactive agent.

The investigator hypothesize that men with thicker plaques with more shadowing as seen on ultrasound imaging. The investigator will test the hypothesis using the following aims:

  • To identify the prevalence of different types and grades of plaques among men with PD
  • To identify pre-treatment factors those predict response to Xiaflex, specifically ultrasonographic characteristics

Condition or disease Intervention/treatment Phase
Peyronie Disease Drug: Xiaflex Phase 4

Detailed Description:

Xiaflex, Collagenase Clostridium histolyticum (CCH) is the only FDA approved medical treatment for correcting penile curvature associated with Peyronie's disease.

Xiaflex is efficacious in approximately 60% of patients with an average improvement in penile curvature of 17 degrees as defined by global response assessment. Identifying predictors of Xiaflex non-response is extremely important, as the treatment is expensive, time- consuming, and may, in some cases be associated with severe adverse effects such as penile pain, hematoma and penile fracture. Prospectively identifying men who are likely to benefit from CCH therapy would provide significant benefits, in terms of safety, resource allocation, and personalized treatment.

Previous analysis indicate that men who were more likely to demonstrate a greater response to Xiaflex were those men with: 1) penile curvature 30-60°; 2) disease duration >4 years; 3) no plaque calcifications; and 4) IIEF score 1-5 (no sexual activity) and ≥17.

Multiple imaging modalities have been evaluated in Peyronie's disease, including ultrasound, CT and MRI. Current evaluation of Peyronie's Disease at the University of Miami incorporates the use of penile duplex ultrasound following administration of intracavernosal vasoactive agent Duplex ultrasound serves two purposes. The first goal of ultrasound is to evaluate underlying vasculogenic etiologies in patients with Peyronie's disease and identify any co-existent erectile dysfunction. The second goal is to characterize the size and location of the plaque.

Ultrasound has been used to categorize Peyronie's plaques based upon the amount of calcification within the plaque: Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing. This will be referred to "Pawlowska Type". A second plaque categorization scheme (plaque grading) was proposed by Levine in 2013 that looked at the size of the plaque calcification on ultrasound: grade 1 (<0.3 cm), grade 2 (>0.3 cm, <1.5 cm), grade 3 (>1.5 cm; or ≥ 2 plaques >1.0 cm). This will be referred as "Levine Grade". In Levine's study, the focus was on progression to surgery and never specifically evaluated the use of Xiaflex.

The investigator hypothesize that men with thicker plaques with more shadowing as seen on ultrasound imaging (Pawlowska type 2 and 3) and larger plaques (Levine grade 2 and 3) will have less improvements in curvature and PDQ score after Xiaflex treatment. Whereas thinner (Pawlowska type 1) and less calcified (Levine grade 1) will have greater improvements in curvature (degree and percent) and PDQ score. The investigator will test the hypothesis using the following aims:

  • To identify the prevalence of different types and grades of plaques among men with PD
  • To identify pre-treatment factors those predict response to Xiaflex, specifically ultrasonographic characteristics

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease
Actual Study Start Date : September 2, 2018
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xiaflex group

Patients will be evaluated in our urology clinic at baseline for possible inclusion in our study. All patients at baseline evaluation will be evaluated for duration of symptoms, relationship stability, IIEF and PDQ. All patients will obtain a penile Doppler ultrasound with the aid of a vasoactive substance by a specially trained technician. During this visit, plaque measurements will be taken: location of plaque, distance of plaque from the tip of the penis, degree of curvature measured by goniometer.

Ultrasound characteristics will be documented: Type (Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing) and Grade of calcification (grade 1 (<0.3 cm), grade 2 (>0.3 cm, <1.5 cm), grade 3 (>1.5 cm; or ≥ 2 plaques >1.0 cm). Sample data sheet attached as appendix 2.

Drug: Xiaflex

The plaque is injected transversely through the width of the plaque, towards the opposite side of the plaque without passing completely through it. For the second injection in a cycle, the site of injection is made approximately 2 to 3 mm apart from the first injection.

Approximately 24 to 72 hours after the second injection of each treatment cycle subjects will undergo investigator initiated penile plaque modeling. The procedure is repeated 3 times (a total of 4 cycles). Subjects are also advised to gently attempt to straighten the penis without pain during spontaneous erection. The treatment cycle is repeated after 6 weeks for up to 4 treatment cycles. Patients may drop out from the study at any time during the study. .

Post-treatment follow up data is collected at 26 weeks (6 months), 39 weeks (9 months) and 52 weeks (12 months) from baseline evaluation. Post treatment measurements will mirror that of baseline evaluation: symptoms, IIEF, PDQ, degree of curvature, penis length.





Primary Outcome Measures :
  1. Psychosexual changes in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 52 weeks ]
    The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months.

  2. Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 52 weeks ]
    The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse.

  3. Goniometer measurement to determine degree of curvature of PD. [ Time Frame: 52 weeks ]
    Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.


Secondary Outcome Measures :
  1. Changes in the International Index of Erectile dysfunction (IIEF) [ Time Frame: 52 weeks ]

    The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.The IIEF-5 score is the sum of the ordinal responses to the 5 items.

    22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Able to provide informed consent
  • A stable relationship for ≥3 months
  • PD symptoms for ≥12 months with evidence of stable disease as determined by the investigator
  • Penile curvature deformity of >30° to <90°
  • Has not had previous surgery for PD
  • Has not had previous therapy with Xiaflex for PD

Exclusion Criteria:

  • Ventral plaque
  • Active phase PD
  • Actively on anticoagulation during time frame of injections
  • Aspirin 81mg will be eligible for therapy
  • Hour glass deformity
  • Previous allergic reaction to Xiaflex
  • Unwilling to participate
  • Medically unfit for sexual intercourse as deemed by the principal investigator
  • Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774264


Contacts
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Contact: Joshua Bitran 305-243-4873 jbitran@sgu.edu
Contact: ranjith ramasamy, MD 305-243-4562 ramasamy@miami.edu

Locations
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United States, Florida
department of Urology, University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Joshua Bitran    305-243-4873    jbitran@sgu.edu   
Principal Investigator: Ranjith Ramasamy, MD         
Sponsors and Collaborators
University of Miami
Endo Pharmaceuticals

Publications of Results:
Other Publications:
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Responsible Party: Ranjith Ramasamy, MD, Director of Male Fertility and Andrology, University of Miami, University of Miami
ClinicalTrials.gov Identifier: NCT03774264     History of Changes
Other Study ID Numbers: 20180188
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases