Resistance Training and Protein Supplementation for Prostate Cancer Survivors

PRIMARY OBJECTIVES:

I. To examine the effects of progressive, structured resistance training (RT) program , with
and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer
survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence
additional outcomes such as physical function, quality of life (QOL) and molecular pathways
that regulate skeletal muscle.

SECONDARY OBJECTIVES:

I. To examine the effects of a structured RT program, with and without PS, on muscle
strength, physical function, and QOL in PCS on ADT .

TERTIARY OBJECTIVES:

I. To examine the effects of a progressive, structured RT program, with and without PS, on
anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.

II. To examine the effects of a progressive, structured RT program, with and without PS, on
bone turnover markers and bone mineral density in PCS on ADT.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static
stretching exercises after each session. Exercises progress from low intensity and high
volume to higher intensity and lower volume over the course of the 12-week program. Patients
also receive whey protein supplementation orally twice a day for 12 weeks.

ARM II: Patients undergo total body RT and stretching as in Arm I.

ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a
home flexibility program 3 times per week, consisting of the same static stretching exercises
performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.

ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient
may undergo total body RT as in Arm 1.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Diagnosed with prostate cancer

- Treatment with androgen deprivation therapy (ADT) (gonadotropin-releasing hormone
[GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer

- Receiving ADT for a minimum of 12 weeks before enrollment into the study

- Planned ADT for the duration of the 12-week study period

- Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related
therapies

- No opioid-requiring cancer related pain

- Any therapy related genitourinary or gastrointestinal symptoms should be
considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade
1 or 2) and not interfering with activities of daily living

- Permission from treating/study physician to participate in RT

Exclusion Criteria:

- No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at
least 4 weeks from study entry)

- History of allergic reactions to whey protein

- Milk protein intolerance/allergies (lactose intolerance is acceptable)

- Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey
protein supplements

- Recovered from major surgery within the last 6 months

- Acute coronary (e.g. myocardial infarction) or vascular event within the last year as
well as uncontrolled coronary heart disease (e.g. progressive angina)

- Stroke within the past 2 years

- Neurologic and/or orthopedic limitations that preclude the participation in the
training program (e.g. bone metastases that may pose a high risk of pathologic
fracture)

- Subjects currently participating in a RT program