Testosterone shots may ease side effects in prostate cancer survivors
NCT ID NCT03716739
First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This phase 2 trial tested whether testosterone replacement therapy could safely improve symptoms like low sex drive and fatigue in 136 men who had their prostate removed for low-risk prostate cancer. Participants received weekly testosterone injections or a placebo for 12 weeks. The study tracked PSA levels and sexual activity to see if the treatment helped without causing cancer to return.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testosterone cypionate (Depo-Testosterone)
- What this could lead to
- If it works, this could offer a way to ease sexual and fatigue-related symptoms in prostate cancer survivors without raising short-term cancer recurrence risk.
- What could go wrong
- This is a small, early-phase trial with only 136 men who had very low-risk cancer. Testosterone may still trigger cancer growth in other patients, and long-term safety is not established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
136 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
-
Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
-
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
-
Johns Hopkins University
Baltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?