Overview

Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

Status:
Unknown status
Trial end date:
2021-09-01
Target enrollment:
0
Participant gender:
Male
Summary
In current clinical practice, an acceptable standard treatment for locally advanced prostate cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group B in this study). However, despite our best treatments, there is a risk that the prostate cancer may eventually return. As well, the hormonal therapy that is given to treat the prostate cancer is known to cause some harmful effects, with some patients using the hormones gaining weight, developing diabetes, having increased cholesterol levels, having increased blood pressure, and/or heart problems. This study is looking at whether Metformin, a drug that is commonly used to treat diabetes, can prevent patients from developing some of the harmful effects of the hormonal therapy. In treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents patients from gaining weight, decreases their cholesterol levels, decreases the number of heart problems and allows patients to live longer. As a result, the researchers in this study are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal therapy by preventing them from developing these problems.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AHS Cancer Control Alberta
Treatments:
Androgens
Metformin
Criteria
Inclusion Criteria:

1. Males ≥ 18 years of age

2. Pathologically confirmed, adenocarcinoma of the prostate with either high-tier
intermediate or high risk prostate cancer:

a. High-tier intermediate risk prostate cancer: i. Gleason score = 7 and PSA 10 - 20
ng/mL b. High risk prostate cancer: i. any T3; or ii. Gleason Score ≥ 8.0; or iii. PSA
≥ 20 ng/mL.

3. Normoglycemic or Impaired Fasting Glucose45 defined as:

1. Fasting Plasma Glucose of ≤ 6.9; or

2. HbA1c of <6.5%

4. Deemed fit to undergo curative intent external beam radiation therapy with concurrent
androgen deprivation therapy by their attending radiation oncologist.

5. Accessible for follow-up clinical and laboratory assessments.

Exclusion Criteria:

1. Patients with evidence (either by imaging or pathology) of distant metastatic spread
of their disease.

a. Patients with pelvic lymph nodes (i.e. N1 disease) are NOT considered to have
distant metastases and can be included in the trial, if meeting the other study
criteria.

2. Patients that meet ≥1 of the Canadian Diabetes Association criteria45 for the
diagnosis of diabetes:

1. Fasting Plasma Glucose of ≥ 7.0 mmol/L; or

2. HbA1C ≥ 6.5%; or

3. Plasma Glucose level of ≥ 11.1 mmol/L 2 hours following a 75g oral glucose load,
if known, within past 28 days; or

4. Random Plasma Glucose level of ≥ 11.1 mmol/L, if known, within past 28 days

3. Patient who currently take metformin or those who have taken metformin within the past
12 months.

4. History of lactic acidosis or conditions that predispose to lactic acidosis
including32:

a. Impaired Renal Function (eGFR < 30); or b. Liver disease, including alcoholic liver
disease, as demonstrated by any of the following parameters: i. AST >1.8 x the upper
limit of normal ii. ALT > 1.8 x the upper limit of normal iii. Alkaline Phosphatase >
2x the upper limit of normal iv. Serum total bilirubin ≥ upper limit of normal c.
Alcohol abuse (habitual intake of ≥3 alcoholic beverages per day) sufficient to cause
hepatic toxicity d. Severe infection

5. Patients with prior bilateral orchiectomy.

6. Patients with prior prostatectomy

7. Patients who are unable to provide informed consent

8. Prior history of malignancy (with exception of adequately treated non-melanomatous
skin cancer or other solid tumors treated curatively with no evidence of disease for ≥
5 years).

9. Patients on hormonal therapy for more than 3 months prior to registration in the
trial.

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