Clinical trial · Interventional
LIpitor and biGuanide to Androgen Delay Trial
A Randomized, Double Blind, Trial of Metformin and Atorvastatin in Delaying Androgen Deprivation Therapy Among Men With Rising PSA Following Radical Prostatectomy or Radiotherapy: The LIGAND (LIpitor and biGuanide to Androgen Delay) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug intervention no longer relevant for the proposed population
Summary
Brief summary (as posted)
This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Placebo (corresponding to atorvastatin) | Drug | — | UNRESOLVED |
| Placebo (corresponding to metformin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin and Atorvastatin
- description
- Atorvastatin 20 mg once daily until progression with one month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.
- interventionNames
- Drug: Metformin
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- One placebo tablet (corresponding to atorvastatin) once daily until progression, with one month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.
- interventionNames
- Drug: Placebo (corresponding to metformin)
- Drug: Placebo (corresponding to atorvastatin)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide informed consent * Histologically confirmed adenocarcinoma of the prostate * History of radical therapy (i.e., radical prostatectomy, radiotherapy, brachytherapy or prostatectomy with salvage radiotherapy) * Serum testosterone levels 8.0 nmol/L (230 ng/dL) or greater * Not currently undergoing treatment for hyperlipidemia or diabetes mellitus * LDL-cholesterol levels 5 mmol/L or lower * HgA1c 6.5% or lower * PSA levels between 2 and 5 ng/mL Exclusion Criteria: * Subjects that have been treated for prostate cancer with any of the following: i. Cytotoxic chemotherapy; ii. Hormonal therapy within past 3 years; iii. Oral glucocorticoids; iv. Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin, degarelix) * Past treatment with the 5-α reductase inhibitors finasteride and dutasteride within past 5 years * Past treatment with drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening * Use of metformin or statins within past 2 years * Planned or concurrent use of metformin, sulfonylureas, thiazolidinediones or insulin for any reason * Known hypersensitivity or intolerance to metformin or atorvastatin * Any clinically significant laboratory abnormalities (e.g., severe renal or hepatic impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial * Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association (NYHA) class III or IV, history of any type of acidosis, habitual intake of 4 or more alcoholic beverages per day) * Abnormal liver function test * Abnormal organ and marrow function
References
Publications (0)
Data not yet available