ASCO GU 2023: A Phase II Trial Modifying Metabolic Syndrome and Cardiovascular Risk for Patients with Prostate Cancer on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring (ProTrio)

( The 2023 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between February 16th and 18th was host to a prostate cancer trials in progress poster session. Dr. Andrew Hahn presented the study design for the ProTrio trial, a phase II trial modifying metabolic syndrome and cardiovascular risk for patients with prostate cancer on androgen deprivation therapy using a risk factor modification program and continuous Fitbit® monitoring.

Prostate cancer patients are typically elderly men, with numerous concurrent age-related illnesses. Androgens play a critical role in prostate cancer pathogenesis, and androgen suppression is the backbone of treatment for numerous patients with advanced prostate cancer. Castration therapy, in the form of androgen deprivation therapy, is associated with the development and/or worsening of cardiovascular disease, metabolic syndrome, bone health, fatigue, and frailty. As such, treatment with androgen deprivation therapy increases the risk of such adverse events in patients at inherently higher risk of such outcomes. Measures to mitigate and potentially improve the cardiovascular/metabolic risk profile for such patients are thus a critical component of their survivorship care. Accordingly, the authors designed the ProTrio trial to test the hypothesis that a 16-week digital risk factor modification program, compared to usual care, will improve 10-year atherosclerotic cardiovascular disease (ASCVD) risk score in men with potentially lethal prostate cancer receiving androgen deprivation therapy.

The ProTrio trial is a single center, open-label, randomized phase II trial that will evaluate a 16-week digital risk factor modification program, which will include an:

  • Exercise prescription: 150 minutes of titrated cardiovascular exercise and resistance exercise twice a week
  • Support via a smart phone application (Moving Analytics) and Fitbit

ProTrio trial.jpg

Eligible patients will be prostate cancer patients with histopathologic diagnosis receiving ADT +/- an androgen signaling inhibitor, for at least three months prior to study entry. This trial will include two patient cohorts:

  1. Distant metastatic disease
  2. Biochemically recurrent or regional nodal disease

Notable exclusion criteria include:

  • Other systemic therapy for prostate cancer
  • Inability to walk 400 meters or do limb exercise
  • Symptomatic bone metastases
  • Radiation or surgery for prior bone metastases
  • Clinically significant cardiac disease

Patients will be stratified according to their baseline ASCVD risk score. The primary endpoint will be the absolute difference in the ASCVD risk score measured at completion of the program (16 weeks). Secondary endpoints will include differences in:

  1. Metabolic severity index z-score
  2. PSA velocity
  3. 6-minute walk ability
  4. 5x sit-to-stand ability
  5. Body composition
  6. Physical activity measured by Fitbit
  7. Health-related quality of life

The target sample size of each cohort will 100 patients (50 patients in each arm; 200 patients total). The pre-defined clinically relevant improvement in ASCVD score is 2.5%. Given the current sample size estimates, with an anticipated 12% dropout rate (44 per arm in each cohort), the study will be powered at an 80% level with a two-sided type 1 level/significance of 5% to detect the clinically relevant improvement in ASCVD score of 2.5% (SD: 4.125%). A sample size adjustment is planned based on the SD of the first cohort to reach 44 patients. Each cohort will undergo a futility analysis once half the patients are enrolled.

The study is currently enrolling at The MD Anderson Cancer Center with an estimated primary completion date of January 2024 (NCT05054296).

Presented by: Andrew Warren Hahn, MD, Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX 

Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, Thurs, Feb 16 – Sat, Feb 18, 2023.


  1. Challa AA, et al. Cardiovascular Toxicities of Androgen Deprivation Therapy. Curr Treat Options Oncol. 2021;22(6):47.