## Protocol Section
### Identification Module
**NCT ID:** NCT06429813

**Brief Title:** Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

**Official Title:** A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/Muscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification

#### Organization Study ID Info
**ID:** HSR230542
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Paul Viscuse

#### Responsible Party

**Investigator Affiliation:** University of Virginia

**Investigator Full Name:** Paul Viscuse

**Investigator Title:** Assistant Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

**Detailed Description:** The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment.

Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs:

* Arm A: A high intensity interval (HIIT) stationary bike program
* Arm B: A walking program

Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team.

Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.

### Conditions Module

**Conditions:**

- Castrate Sensitive Prostate Cancer

- Metastatic Prostate Cancer

**Keywords:**

- prostate

- metastatic prostate cancer

- metastatic castrate-sensitive prostate cancer

- prostate cancer

- exercise

- ADT

- ARSI

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HIIT Cycling Intervention

**Intervention Names:**

- Behavioral: Home-Based Exercise Intervention - HIIT Cycling

**Label:** Arm A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Walking Intervention

**Intervention Names:**

- Behavioral: Home-Based Exercise Intervention - Walking

**Label:** Arm B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm B

**Description:** 30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks

**Name:** Home-Based Exercise Intervention - Walking

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Arm A

**Description:** Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks

**Name:** Home-Based Exercise Intervention - HIIT Cycling

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants who complete the post-intervention follow-up assessment

**Measure:** Number of participants who complete the post-intervention follow-up assessment

**Time Frame:** 14 weeks from the start of the intervention

#### Secondary Outcomes

**Description:** Frequency, intensity and duration of exercise as measured by the activity monitors.

**Measure:** Treatment engagement with intervention

**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

**Description:** The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.

**Measure:** Acceptability of exercise

**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

**Description:** Exit interviews include open and closed ended questions about the participant's experience in the study.

**Measure:** Patient-reported outcomes on exercise

**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)

**Description:** Number of individuals screened and randomized

**Measure:** Rate of recruitment per month

**Time Frame:** Each month for 12 months (estimated duration of accrual of participants)

**Description:** As measured by VO2 peak

**Measure:** Physical fitness (Cardiorespiratory)

**Time Frame:** Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)

**Description:** Isometric and isokinetic torque in multiple positions (e.g. 60-120 degrees)

**Measure:** Muscular strength (quadriceps)

**Time Frame:** Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, aged ≥18 years old
4. Diagnosis of mCSPC (defined as either biopsy-proven metastatic prostate cancer or elevated PSA (Prostate Specific Antigen) in the setting of imaging findings typical of prostate cancer spread; patients can either have de novo metastatic disease or recurrent metastatic disease after prior definitive therapy to the primary tumor with either surgery or radiation)
5. Planned treatment with ADT (LHRH \[Luteinizing hormone-releasing hormone\] agonist such as leuprolide or LHRH antagonist such as degarelix), and intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide)
6. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.
7. Ability to take oral medication and willing to adhere to the study intervention regimen
8. Ability to read, speak, and understand English.

Exclusion Criteria:

1. Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of disease on imaging PSA progression with PSA increase of \> 25% and 2 ng/mL above nadir, confirmed at 2 time points at least 3 weeks apart, in the setting of testosterone level \< 50)
2. Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA \[Prostate-Specific Antigen\] rise) but radiographic imaging is negative for metastatic disease
3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician
4. Medical/orthopedic comorbidities that preclude stationary cycling or walking
5. Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
6. Unstable angina or myocardial infarction within 4-weeks prior to treatment
7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms
8. Symptomatic severe aortic stenosis
9. Acute pulmonary embolus
10. Acute myocarditis
11. Untreated high-risk proliferative retinopathy
12. Recent retinal hemorrhage
13. Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg)
14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator
15. Uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema)
16. Symptomatic peripheral vascular disease
17. Prior treatment with taxane- or platinum- based chemotherapy
18. Prior treatment with PARP \[Poly (ADP-ribose) polymerase\] inhibitors
19. Prior treatment with radium-223 or lutetium-177

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** WRS9HW@uvahealth.org

**Name:** Steven Goff

**Phone:** 434-806-1357

**Role:** CONTACT

**Contact 2:**

**Email:** CMP2P@uvahealth.org

**Name:** Christine Martin

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlottesville

**Contacts:**

***Contact 1:***

- **Email:** WRS9HW@uvahealth.org

- **Name:** Steven Goff

- **Phone:** 434-806-1357

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Virginia

**State:** Virginia

**Zip:** 22908

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia

**Name:** Paul Viscuse, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Sensitive

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

- ID: D000006967

- Term: Hypersensitivity

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4059

- Name: Androgens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
