Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    142
  • sponsor
    Dana-Farber Cancer Institute
Updated on 9 February 2022
prostatectomy
androgens
testosterone
prostate specific antigen
serum testosterone

Summary

The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.

Description

The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score < 7 (3+4), who have undetectable PSA (<0.1 ng/mL using a sensitive PSA assay) for > 2 years after radical prostatectomy, and who have androgen deficiency.

Details
Condition Prostate Cancer
Treatment Placebo, Testosterone Cypionate 100 MG/ML
Clinical Study IdentifierNCT03716739
SponsorDana-Farber Cancer Institute
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the
gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA
less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL
using an assay that has a functional sensitivity of 0.1 ng/mL) for at least
two years after radical prostatectomy
Age: 40 years and older
Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction
An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL. middle-aged and older men with mean testosterone levels > 300 ng/dL
Ability and willingness to provide informed consent

Exclusion Criteria

Men who have undergone radiation therapy
Men receiving androgen deprivation therapy will be excluded
Hemoglobin <10 g/dL or >16.5 g/dL
Severe untreated sleep apnea
Allergy to sesame oil
Uncontrolled heart failure
Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
Hemoglobin A1c >7.5% or diabetes requiring insulin therapy
Body mass index (BMI) >40 kg/m2
Untreated depression. Subjects with depression who have been on stable anti-depressant medication, or undergoing CBT for more than three months are eligible
Men with axis I psychiatric disorder, such as schizophrenia, will be excluded
Subjects who have used the following medications within the past 6 months: testosterone, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone, ketoconazole, rhGH, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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