Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This study will examine the role of Metformin as a means to prevent increases in weight as well as the prevalence and severity of metabolic syndrome, with their associated morbidity, amongst men with locally advanced, biopsy confirmed adenocarcinoma of the prostate (PCa) that are planned to receive curative intent therapy with androgen deprivation therapy (ADT) and external beam radiotherapy (EBRT) to the prostate. Males of any age with biopsy confirmed high tier intermediate risk PCa (Gleason score 7 and PSA 10-20) or high risk PCa (any T3; and/or Gleason Score ≥ 8.0; and/or PSA ≥ 20 ng/mL) ECOG 0 to 1, non-diabetic with no evidence of metastatic PCa will be randomized to either: Group A: Metformin 500mg PO TID x 30-36 months total, with neoadjuvant and adjuvant ADT x18-36 months and EBRT of 46 Gy/23# to pelvic lymph nodes (optional); plus prostate boost to 78 Gy/39# or brachytherapy boost (110-115 Gy) or hypofractionated equivalent OR Group B: Identical placebo TID x 20-36 months total, with neoadjuvant and adjuvant ADT x18-36 months and EBRT of 46 Gy/23# to pelvic lymph nodes (optional); plus prostate boost to 78 Gy/39# or brachytherapy boost (110-115 Gy) or hypofractionated equivalent A planned sample size of 104 patients will provide 97% power for a 2-tailed α of 0.05 to detect 4 kg difference in weight at 12 months of follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01996696
Study type Interventional
Source AHS Cancer Control Alberta
Contact
Status Terminated
Phase Phase 2
Start date September 2014
Completion date November 2020

See also
  Status Clinical Trial Phase
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Recruiting NCT05667636 - Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP Phase 2
Completed NCT01431391 - Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer Phase 2
Completed NCT03289130 - Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
Recruiting NCT04462926 - Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed N/A
Completed NCT00001446 - A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer Phase 2
Completed NCT02729103 - Treatment Patterns in Metastatic Prostate Cancer N/A
Completed NCT00956228 - Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer Phase 1/Phase 2
Completed NCT00126854 - High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation N/A
Completed NCT00247312 - Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial Phase 3
Completed NCT00174863 - Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer Phase 2
Terminated NCT04221828 - Trial of NanoPac Focal Therapy for Prostate Cancer Phase 2
Completed NCT00001266 - A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma Phase 2
Active, not recruiting NCT03935282 - Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors N/A
Completed NCT03693742 - MSG Use With 18F-DCFPyL PET/CT Imaging N/A
Recruiting NCT06236789 - Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
Completed NCT02977143 - Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery N/A
Completed NCT02966535 - The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial N/A
Completed NCT00252460 - CT/MRI Co-registration Prostate Cancer Phase 1
Completed NCT04398173 - Detection Rate of Prostate Cancer in Men Undergoing MRI