Repurposing Metformin as Anticancer Drug: in Advanced Prostate Cancer

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluate the addition of metformin to standard of care in locally advanced and metastatic prostate cancer, half the patient will receive metformin in combination with standard treatment, and the other half will receive the standard of care only

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. High-risk newly diagnosed non-metastatic node-negative disease at least two of:

• Stage T3/4, PSA≥40ng/ml or Gleason sum score 8-10

• Intention to treat with radical radiotherapy (unless there is a contraindication)

2. OR newly diagnosed metastatic or node-positive disease at least one of:

• Stage T any N+ M0

• Stage T any Nany M+

3. OR previously treated with radical surgery and/or radiotherapy, now relapsing

At least one of:

(-PSA ≥4ng/ml and rising with doubling time less than 6 months,N+, M+)

4. And for all patients

• Age > 18 years

• Histologically confirmed prostate adenocarcinoma

• Intention to treat with long-term androgen deprivation therapy

• Fit for all protocol treatment and follow-up, ECOG performance status 0-2

• Diabetic and non-diabetic patients

• Patients with adequate organ function(AST - ALAT ≤ 2.5x ULN,Bilirubin ≤ 1.5 x ULN)

Exclusion Criteria:

1. Age < 18 years

2. Excessive alcohol intake, acute or chronic

3. Patients already treated with Metformin or an analoge

4. Known hypersensitivity or allergy to Metformin or any of the excipients.

5. Patients with a history of lactic acidosis

6. Patient treated for a cancer other than prostate cancer, with the exception of basal cell carcinoma

7. Acute or chronic metabolic acidosis.

8. Patients suffering from severe dehydration.

9. Patients with chronic heart failure.

10. Patients with hepatic impairment.

11. Patients with severe renal disease.