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Cancer of ProstatePhase 2BIMET-1NCT02614859

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

A Phase 2 study testing Observation and Bicalutamide and Metformin and Bicalutamide in people with Cancer of Prostate, run by Fox Chase Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer of Prostate
What is being tested?
Observation and Bicalutamide and Metformin and Bicalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
1 Dec 2015to 24 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent
  • Male 18 years or older
  • Histologically or cytologically confirmed diagnosis of prostate cancer
  • Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation
  • Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure.Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed BMI > 25 at study entry
  • Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSADT were documented after the testosterone level was > 150ng/dL.
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  • Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 12 weeks prior to randomization.
  • PSA must be < 30 ng/mL at study entry
  • Patient may not have had therapy modulating testosterone levels (such as luteinizing hormone,releasing-hormone agonists/antagonists and antiandrogens) within 1 year prior to randomization, unless it was in the neoadjuvant and/or adjuvant setting
  • Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy.
  • For radical prostatectomy the threshold for this study is PSA ≥ 0.2ng/mL
  • For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition).
  • PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached.
  • PSA doubling time between 3 and 9 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab. Patient's PSA doubling time must be calculated using the following formula (http://www.mskcc.org/nomograms/prostate/psa doubling-time):
  • ECOG performance status less than or equal to 2
  • Ability to swallow the study drugs
  • Subjects must have normal organ and marrow function as defined below:
  • Absolute neutrophil count greater than or equal to 1,000/mL
  • Hemoglobin greater than or equal to 10 g/dL
  • Platelets greater than or equal to 100,000/mL
  • Total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) less than or equal to 1.5 X institutional ULN
  • Creatinine clearance greater than or equal to 60 mL/min/1.73 m2
  • Hgb A1c ≤ 6.5

Who cannot join

  • Evidence of metastatic disease on imaging studies (CT and/or bone scan)
  • Diagnosis of diabetes mellitus defined as
  • Fasting blood glucose > 126 mg/dl or,
  • Random blood glucose > 200 mg/dl
  • Hemoglobin A1C > 6.5%
  • Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy)
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  • Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and greater than 6 months before entry is acceptable)
  • Treatment within the last 30 days with any investigational drug
  • Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed)
  • Known hypersensitivity to metformin
  • Prior history of lactic acidosis
  • Any history of myocardial infarction in the past 12 months
  • Subjects who consume more than 3 alcoholic beverages per day Subjects with serious intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other nonmalignant medical or psychiatric illness that is uncontrolled or whose control may be jeopardized by the complications of this therapy or may limit compliance with the study requirements (at the discretion of the investigator)
  • Patient with previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions: Basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for ≥ 2 years.
  • Subjects currently treated with metformin and/or bicalutamide or who have been treated with metformin and/or bicalutamide in the past 6 months.
  • Subjects who have taken 5a-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last 6 weeks are ineligible. Subjects will be eligible for the study after the wash out period of 6 weeks.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Cancer Institute

    Bethesda, Maryland, 20892-9760

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Observation and Bicalutamide, Metformin and Bicalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observation and BicalutamideDrug

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

  • Metformin and BicalutamideDrug

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

Study groups in NCT02614859
Study groupRoleWhat they receive
Observation and BicalutamideActive comparatorCycles 1-2: Observation without treatment Cycles 3-8: Bicalutamide 50 mg daily continuously to end of study
Receives: Drug: Observation and Bicalutamide
Metformin and BicalutamideExperimentalCycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID
Receives: Drug: Metformin and Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical Response Rate Based on PSA

    Participants with undetectable PSA after 32 weeks

    Measured: 32 weeks

Secondary outcomes (4)

  1. PSA Decline ≥ 85% at 32 Weeks

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

    Measured: 32 Weeks

  2. PSA Decline

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

    Measured: 8 Weeks

  3. Median PSA Decline

    Median PSA decline after 8 weeks % (range)

    Measured: 8 weeks

  4. BMI Decline After 32 Weeks

    Number of patients with BMI decline after 32 weeks

    Measured: 32 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion24 Jan 2020
  4. Study completion24 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614859
Sponsor's protocol ID
GU-079
Other IDs
15-1015
Acronym
BIMET-1
Status last verified
Mar 2022
First submitted
18 Nov 2015
Last updated
29 Mar 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bilusic M, Toney NJ, Donahue RN, Wroblewski S, Zibelman M, Ghatalia P, Ross EA, Karzai F, Madan RA, Dahut WL, Gulley JL, Schlom J, Plimack ER, Geynisman DM. A randomized phase 2 study of bicalutamide with or without metformin for biochemical recurrence in overweight or obese prostate cancer patients (BIMET-1). Prostate Cancer Prostatic Dis. 2022 Apr;25(4):735-740. doi: 10.1038/s41391-022-00492-y. Epub 2022 Jan 25.

    PubMed 35079115

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Observation and Bicalutamide and Metformin and Bicalutamide in people with Cancer of Prostate, run by Fox Chase Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical Response Rate Based on PSA (time frame: 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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