Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Overweight

Recurrence

Prostatic Neoplasms

Obesity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Overnutrition

Nutrition Disorders

Body Weight

Disease Attributes

Hypoglycemic Agents

All Drugs and Chemicals

Antineoplastic Agents

Metformin

Bicalutamide

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Cycles 1-2: Observation without treatment Cycles 3-8: Bicalutamide 50 mg daily continuously to end of study

Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID

Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32).

Observation and Bicalutamide

Metformin and Bicalutamide

Daniel Geynisman, MD

Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer.

1 Cycle = 28 days = 4 weeks. Treatment will be administered on an outpatient basis ӿ Metformin starting dose is 500 mg BID, will be gradually increased to target dose of 1000mg BID.

Treatment ARM A Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32).

Treatment ARM B Cycles 1 - 2: In order to minimize gastrointestinal discomfort, metformin dosing will be ramped up over a period of 2 weeks. Metformin treatment will be started at 500 mg BID (Dose Level -2) and increased by an increment of 500 mg daily every week +/- 2 days provided no grade 2 or higher gastrointestinal toxicity is noted. If grade 2 or greater gastrointestinal toxicity occurs during the first 4 weeks of treatment, the subject will be evaluated every 2 weeks until resolution of toxicity to grade 0 or 1 and, then, the metformin dose will be increased to the next dose level. The target dose of metformin is 1000 mg BID.

Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients

Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)

Participants with undetectable PSA after 32 weeks

Number of patients with PSA decline ≥ 85% after 32 weeks

Number of patients with PSA decline after 8 weeks (observation vs metformin)

Median PSA decline after 8 weeks % (range)

Number of patients with BMI decline after 32 weeks

Fox Chase Cancer Center

Participants will be followed every 12 months (+/- 2 months) for up to 4 years 1 month from end of treatment for survival, adverse events, and disease status

Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8

Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3

Total

Age, Continuous

Sex: Female, Male

White Non-Hispanic

Black or African American

Race/Ethnicity, Customized

United States

Region of Enrollment

Participant in metformin and bicalutamide arm removed from study due to non-compliance

Dr. Daniel Geynisman

29 patients were found eligible and randomized, 28 patients completed all 32 weeks of the trial, and one patient in Arm B was lost to follow-up.

Biochemical Response Rate Based on PSA

Cycles 1-2: Observation without treatment Cycles 3-8: Bicalutamide 50 mg daily continuously to end of study

Bicalutamide: Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32).

Arm A

Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID

Metformin and Bicalutamide: Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients	NCT02614859	Cancer of Prost...	Observation and... Metformin and B...	18 Years -	Fox Chase Cancer Center
Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients	NCT02614859	Cancer of Prost...	Observation and... Metformin and B...	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for metformin and bicalutamide