Clinical trial · Interventional
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
NCT03716739CI-TRIAL-00118265completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Testosterone Cypionate 100 MG/ML | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment Arm
- description
- Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.
- interventionNames
- Drug: Testosterone Cypionate 100 MG/ML
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- Weekly IM administration of placebo for 12 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Number of Participants With Biochemical Recurrence of Prostate Cancer
- timeFrame
- the 12-week treatment and the 3-month follow-up
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBhasin 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
- DERIVEDSentana-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