Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

NCT03716739 | Completed Phase 2 Results 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)

• Number of Participants With Biochemical Recurrence of Prostate Cancer

  The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.

  the 12-week treatment and the 3-month follow-up

• Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4

  The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ 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 activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.

  Week 6, Week 12

Secondary Outcomes (18)

• Change in PSA

  Week 12

• Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)

  Week 6, Week 12

• Change From Baseline in Hemoglobin

  Week 6, Week 12

• Change From Baseline in Hematocrit

  Week 6, Week 12

• Number of Participants With Erythrocytosis in the Two Study Arms

  Week 12

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

Related Publications (2)

• Bhasin S, Burnett AL, Gagliano-Juca T, Storer TW, Reid KF, Shang YV, Privat F, Chandra MS, Weiss M, Memish-Beleva Y, Lam H, Kibel AS, Pencina KM. Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 1;186(7):805-814. doi: 10.1001/jamainternmed.2026.1343.

  PMID: 42113507 DERIVED

• Sentana-Lledo D, Saraf A, Morgans AK. Symptom Burden and Survivorship Care for Patients With Prostate Cancer on Androgen Deprivation Therapy. J Natl Compr Canc Netw. 2024 Dec 20;23(1):e247047. doi: 10.6004/jnccn.2024.7047.

  PMID: 39705803 DERIVED

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

Results Point of Contact

• Title: Dr Shalender Bhasin
• Organization: Brigham and Women's Hospital

sbhasin@bwh.harvard.edu

617-525-9150

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 16, 2026
• Results First Posted: July 16, 2026

Record last verified: 2025-01

Locations

US (3)