Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02614859 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Fox Chase Cancer Center.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT02614859: Completed Phase 2 study, sponsored by Fox Chase Cancer Center.

NCT02614859 is a Phase 2 study that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02614859, a Phase 2 study, has completed, sponsored by Fox Chase Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study 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. 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.

Primary Outcome

Participants with undetectable PSA after 32 weeks

Interventions

  • DRUG Observation and Bicalutamide
  • DRUG Metformin and Bicalutamide

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2015-12-01
Est. Completion 2020-01-24
Phase Phase 2
Fox Chase Cancer Center

183 total trials

What the finished NCT02614859 record still lists

NCT02614859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Observation and Bicalutamide is the first listed.

NCT02614859 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02614859 about?

NCT02614859 is a clinical study titled "Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients". 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 (...

What is the current status of trial NCT02614859?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2015-12-01. Estimated completion is 2020-01-24.

What interventions are being tested in trial NCT02614859?

The interventions under investigation include: Observation and Bicalutamide (DRUG), Metformin and Bicalutamide (DRUG).

Who is sponsoring clinical trial NCT02614859?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02614859's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02429557 · 29 participants · Phase 1

    Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

  • NCT02568878 · 29 participants · Phase 3

    Creatine for Depressed Male and Female Methamphetamine Users

  • NCT03014401 · 29 participants · NA

    The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

  • NCT03128996 · 29 participants · Phase 1

    Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02614859, the US trial registry maintained by the National Library of Medicine. NCT02614859 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.