Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Male

Summary

In this open-label, six-month, pilot study of men with Peyronie's disease there will be one subject group consisting of 20 subjects. All subjects will receive Xiaflex® plus testosterone (T) treatment (Aveed®). Males included in the study must be 18-70 years old; have a history of PD for more than six months; and have at two serum total testosterone level less than 350 ng/dL within 30 days prior to enrollment. The primary objective of this pilot study is to determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase clostridium histolyticum) in subjects undergoing treatment for Peyronie's disease.

Endpoints will include reduction in degree of curvature and response to the PDQ questionnaire. Secondary objectives will be to assess men for change in plaque size, quality of life parameters, and sexual function. Data collected from this pilot study will be analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. This pilot study will establish preliminary evidence needed to continue more in-depth research regarding Xiaflex® with T therapy and serve as a means to evaluate feasibility of a full-scale study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Men's Health Boston
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Ability to read, write, and understand English

2. Age greater than or equal to 18

3. Age less than or equal to 70

4. Identification of acquired penile curvature of greater than 30 degrees and less than 90 degrees associated with palpable penile plaque on physical examination at screening

5. Screening total testosterone of less than 350 ng/dL, twice withine 30 days of treatment

6. Screening free testosterone of less than 1.5ng/dL (analog assay) or 100pg/mL (calculated)

7. Planning to initiate Xiaflex® injections at MHB

8. Willingness to initiate testosterone therapy

9. Willing to be followed at MHB for the next 3 months

10. Willing to provide informed consent for this study

Exclusion Criteria:

1. Prior history of treatment for PD that includes surgery

2. Prior treatment with oral therapy for PD unless at least stopped 2 weeks prior to signing the informed consent (e.g. Potaba, Vitamin E, colchicines)

3. Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks

4. Presence of dense calcified plaque by ultrasound at screening

5. Hypersensitivity to testosterone, stearic acid, or polyvinylpyrolidone (the constituents of Aveed®)

6. Unwillingness to start testosterone therapy

7. Screening total testosterone of greater than 350 ng/dL

8. Screening free testosterone of more than 1.5ng/dL (analog assay) or 100pg/mL (calculated)

9. Unable to achieve adequate erection with penile injection to assess degree of curvature

10. Prior history of definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy

11. Prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease

12. Prior history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea

13. Screening PSA more than 4.0 ng/mL, unless prostate cancer has been excluded to the Investigator's satisfaction

14. Incapable of giving informed consent or complying with the protocol