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NCT Number: NCT07746414

Effects of Exercise Prior to Radical Prostatectomy

This pilot study will explore the metabolic and psychological effects of High-Intensity Interval Training (HIIT) exercise as well as its impact on patient recovery from radical prostatectomy.

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Key information

Conditions

Recovery Post Prostatectomy

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

Participants will have a minimum of fourteen study visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled or intended treatment with radical prostatectomy at Yale New Haven Hospital
  • English language fluency
  • Clinically localized low, intermediate or high risk by National Comprehensive Cancer Network (NCCN) criteria
  • Able to attend 2 in person exercise training sessions per week for four-six weeks

Exclusion criteria

  • Treatment with non-surgical modality
  • Prior therapy for prostate cancer (e.g. radiation therapy or focal therapy)
  • Already engaged in regular exercise (>60 minutes per week)
  • Unstable cardiovascular disease
  • Physical mobility limitation, unable to walk or exercise
  • Locally advanced (cT4 or cN1 or cM1) prostate cancer
  • Prior treatment with androgen deprivation therapy

Treatment and study plan

High-Intensity Interval Training (HIIT) Exercise

Behavioral

The intervention will consist of vigorous physical activity for a goal of 60 minutes each week for a minimum of four weeks prior to prostatectomy.

Primary outcomes

  1. Mean concentration N-lactoyl phenylalanine

    Time frame: Pre-exercise (Baseline) and post-excercise (4 weeks)

    Mean concentration N-lactoyl phenylalanine (pg/ml) in blood

Secondary outcomes

  1. Mean score Memorial Anxiety Scale for Prostate Cancer (MAXPC)

    Time frame: Pre-exercise (Baseline) and post-exercise (4 weeks)

    Questionnaire specifically designed to identify and measure cancer-related anxiety in men diagnosed with prostate cancer. Total score range is 0 to 54, with a higher score indicating a greater level of anxiety.

  2. Mean score Expanded Prostate Cancer Index Composite Short Form (EPIC-26)

    Time frame: Pre-exercise (Baseline) and post-exercise (4 weeks)

    A comprehensive instrument designed to evaluate patient function and bother after prostate cancer on five health-related quality of life domains each scored on a scale of 0 to 100. Higher scores indicate better function and fewer symptoms or lower treatment bother.

  3. Percentage of participants that used opioids

    Time frame: Post operative (Day 1)

    Percentage of participants that used opioids post prostatectomy

  4. Percentage of participants readmitted

    Time frame: Post operative (Day 1) up to 12 weeks

    Percentage of participants readmitted to hospital post prostatectomy.

  5. Mean number ER visits

    Time frame: Post operative (Day 1) up to 12 weeks

    Mean number ER visits post prostatectomy

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Linsky, MPH

CONTACT

[email protected]

475-375-6129

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Effects of High Intensity Interval Training Among Patients With Prostate Cancer Prior to Radical Prostatectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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