Trial Outcomes & Findings for Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (NCT NCT02614859)

NCT ID: NCT02614859

Last Updated: 2022-03-29

Results Overview

Participants with undetectable PSA after 32 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

32 weeks

Results posted on

2022-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Bicalutamide Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
Overall Study STARTED	9	20
Overall Study COMPLETED	9	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bicalutamide Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
Overall Study Physician Decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=20 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3	Total n=29 Participants Total of all reporting groups
Age, Continuous	63 years n=93 Participants	64 years n=4 Participants	63.7 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	20 Participants n=4 Participants	29 Participants n=27 Participants
Race/Ethnicity, Customized White Non-Hispanic	6 Participants n=93 Participants	19 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	9 Participants n=93 Participants	20 Participants n=4 Participants	29 Participants n=27 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: 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.

Participants with undetectable PSA after 32 weeks

Outcome measures

Outcome measures
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
Biochemical Response Rate Based on PSA	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 32 Weeks

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

Outcome measures

Outcome measures
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
PSA Decline ≥ 85% at 32 Weeks	6 Participants	10 Participants

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Outcome measures
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
PSA Decline	1 Participants	8 Participants

SECONDARY outcome

Timeframe: 8 weeks

Median PSA decline after 8 weeks % (range)

Outcome measures

Outcome measures
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
Median PSA Decline	NA percent change Interval 0.0 to 0.0 Only 1 patient had a PSA decline in Arm A	9 percent change Interval 4.0 to 24.0

SECONDARY outcome

Timeframe: 32 Weeks

Number of patients with BMI decline after 32 weeks

Outcome measures

Outcome measures
Measure	Bicalutamide n=9 Participants Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 Participants Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
BMI Decline After 32 Weeks	4 Participants	12 Participants

Adverse Events

Bicalutamide

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Metformin and Bicalutamide

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Daniel Geynisman

Fox Chase Cancer Center

Phone: 215-728-3889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Bicalutamide n=9 participants at risk Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8	Metformin and Bicalutamide n=19 participants at risk Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	22.2% 2/9 • 4 years 1 month 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	42.1% 8/19 • 4 years 1 month 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
Reproductive system and breast disorders Gynecomastia	33.3% 3/9 • 4 years 1 month 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	21.1% 4/19 • 4 years 1 month 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
Reproductive system and breast disorders Breast Pain	22.2% 2/9 • 4 years 1 month 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	15.8% 3/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hyperglycemia	33.3% 3/9 • 4 years 1 month 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	26.3% 5/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/9 • 4 years 1 month 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	26.3% 5/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hypernatremia	0.00% 0/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Metabolism and nutrition disorders Anorexia	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hypoglycemia	11.1% 1/9 • 4 years 1 month 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	0.00% 0/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • 4 years 1 month 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	0.00% 0/19 • 4 years 1 month 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
Metabolism and nutrition disorders Hyponatremia	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Diarrhea	11.1% 1/9 • 4 years 1 month 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	42.1% 8/19 • 4 years 1 month 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
Gastrointestinal disorders Nausea	0.00% 0/9 • 4 years 1 month 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	21.1% 4/19 • 4 years 1 month 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
Gastrointestinal disorders Constipation	0.00% 0/9 • 4 years 1 month 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	15.8% 3/19 • 4 years 1 month 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
Gastrointestinal disorders Abdominal Pain	0.00% 0/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Gastrointestinal disorders Bloating	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Dry Mouth	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Gastritis	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Gastrointestinal disorders - Other	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Gastrointestinal disorders Vomiting	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Investigations Alanine aminotransferase increased	22.2% 2/9 • 4 years 1 month 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	21.1% 4/19 • 4 years 1 month 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
Investigations Weight loss	0.00% 0/9 • 4 years 1 month 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	21.1% 4/19 • 4 years 1 month 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
Investigations Aspartate aminotransferase increased	11.1% 1/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Investigations Investigations - Other	11.1% 1/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Investigations Cholesterol high	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Investigations Platelet count decreased	11.1% 1/9 • 4 years 1 month 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	0.00% 0/19 • 4 years 1 month 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
General disorders Fatigue	22.2% 2/9 • 4 years 1 month 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	26.3% 5/19 • 4 years 1 month 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
General disorders General disorders and administration site conditions	22.2% 2/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
General disorders Edema limbs	22.2% 2/9 • 4 years 1 month 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	0.00% 0/19 • 4 years 1 month 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
General disorders Pain	11.1% 1/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
General disorders Injection site reaction	11.1% 1/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Vascular disorders Hot flashes	33.3% 3/9 • 4 years 1 month 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	15.8% 3/19 • 4 years 1 month 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
Vascular disorders Hypertension	0.00% 0/9 • 4 years 1 month 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	10.5% 2/19 • 4 years 1 month 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
Vascular disorders Flushing	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Vascular disorders Hypotension	0.00% 0/9 • 4 years 1 month 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	5.3% 1/19 • 4 years 1 month 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
Blood and lymphatic system disorders Anemia	22.2% 2/9 • 4 years 1 month 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	15.8% 3/19 • 4 years 1 month 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
Nervous system disorders Dizziness	0.00% 0/9 • 4 years 1 month 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	15.8% 3/19 • 4 years 1 month 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