Recruiting
Phase 1
Phase 2

Behavioral Exercise Training

Sponsor:

Virginia Commonwealth University

Code:

NCT06237179

Conditions

Prostate Cancer

Supportive Care

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Training Intervention

Healthy Living Education

Study Details

Brief summary:

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

Conditions

Prostate Cancer

Supportive Care

Study ID

NCT06237179

Start date

Feb 21, 2024

Status verified date

Feb, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be diagnosed with stage II/III/IV prostate cancer
  • Be currently undergoing treatment with ADT (intermittent or prolonged)
  • Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
  • Be >40 years of age up to 85;
  • Be willing to sign an informed consent with HIPAA authorization form;
  • Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
  • Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
  • Be without any serious medical condition that precludes safe participation in an exercise program;
  • Speak English

Exclusion Criteria:

  • Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
  • Have contraindications to exercise testing;
  • Have pre-existing overt cardiovascular disease/heart failure;
  • Active illness/infection;
  • Hemoglobin < 7.0 grams/dL
  • Platelet count < 10 x 109/L

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise Training Intervention

The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity

active comparator: Healthy Living Education Control

Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

Interventions

Exercise Training Intervention

5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.

Healthy Living Education

During the initial 12 weeks of the study, men randomized to the HLE group will receive educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

Primary outcome measure

  • Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
  • Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts and Locations

Central contacts

Alexander R Lucas, PhD

804 628-6610Alexander.Lucas@vcuhealth.org

Alexandra Marshall, MS

804 628-1215lara.marshall@vcuhealth.org

Locations

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Alexandra Marshall

marshallla@vcu.edu

Alexander Lucas, PhD

804-628-6610Alexander.Lucas@vcuhealth.org

Principal Investigator:

Alexander Lucas, Ph.D

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Prostate Cancer
  • Supportive Care
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-03-02.