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New treatment option for Castrate Sensitive Prostate Cancer
Official title Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
ClinicalTrials.gov ID: NCT06429813
What this study is testing
- What it's testing
- 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).
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Planned treatment with ADT (LHRH [Luteinizing hormone-releasing hormone] agonist such as leuprolide or LHRH antagonist such as degarelix), or recent...
You likely can't join if
- Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of...
- Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA [Prostate-Specific Antigen]...
- Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by...
- Medical/orthopedic comorbidities that preclude stationary cycling or walking
- Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
- Unstable angina or myocardial infarction within 4-weeks prior to treatment
See the full eligibility 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...
- 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
- Ability to read, speak, and understand English.
- 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...
- 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
- Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician
- Medical/orthopedic comorbidities that preclude stationary cycling or walking
- Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
- Unstable angina or myocardial infarction within 4-weeks prior to treatment
- Complex ventricular arrhythmias or New York Heart Association class IV symptoms
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Untreated high-risk proliferative retinopathy
- Recent retinal hemorrhage
- Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg)
- Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator
- Uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema)
- Symptomatic peripheral vascular disease
- Prior treatment with taxane- or platinum- based chemotherapy
- Prior treatment with PARP [Poly (ADP-ribose) polymerase] inhibitors
- Prior treatment with radium-223 or lutetium-177
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.