Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

NCT03716739 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 18-7335R01AG060539-05
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• PSA Recurrence

  The proportion of enrolled participations with PSA recurrence.

  5-8 months

• Change in sexual activity

  Change in sexual activity is assessed by the Psychosexual Daily Questionnaire (PDQ), question 4. Subjects complete the questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual desire, sexual enjoyment, and mood are rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating high. Activity is assessed using a checklist. Subjects record whether they had sexual daydreams; anticipation of sex; flirting; sexual interactions; and erection, masturbation, intercourse, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for analysis. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score is 0 if no activity has taken place. Higher values indicate more activity and lower values indicate lower activity.

  5-8 months

Secondary Outcomes (12)

• Change in PSA

  Baseline to 5-8 months

• Clinical Disease Recurrence

  5-8 months

• Change in sexual desire

  5-8 months

• Change in erectile function

  5-8 months

• Change in energy level

  5-8 months

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.

Drug: Testosterone Cypionate 100 MG/ML

Control Arm

PLACEBO COMPARATOR

Weekly IM administration of placebo for 12 weeks.

Drug: Placebo

Interventions

Testosterone Cypionate 100 MG/ML DRUG

100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.

Also known as: Depo-Testosterone

Treatment Arm

Placebo DRUG

Placebo administered by intramuscular injection weekly for 12 weeks.

Also known as: Inactive comparator

Control Arm

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Males with a history of prostate cancer who have undergone prostatectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 23, 2018
• Study Start: March 19, 2019
• Primary Completion: May 16, 2025
• Study Completion: July 16, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-01

Locations

US (3)