RecruitingNot Applicable

Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

United States24 participantsStarted 2024-07-26

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male, aged ≥18 years old
✓. 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)
✓. Planned treatment with ADT (LHRH \[Luteinizing hormone-releasing hormone\] agonist such as leuprolide or LHRH antagonist such as degarelix), or recent administration, ≤14 days prior to enrollment.
✓. Planned intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide).
✓. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.
✓. Ability to take oral medication and willing to adhere to the study intervention regimen

Exclusion criteria

What they're measuring

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

Timeframe: 14 weeks from the start of the intervention

Trial details

NCT IDNCT06429813

SponsorPaul Viscuse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Steven Goff

434-806-1357 WRS9HW@uvahealth.org

View on ClinicalTrials.gov More Castrate Sensitive Prostate Cancer trials