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New treatment option for Prostate Cancer Metastatic
Official title Exercise in Prostate Cancer
ClinicalTrials.gov ID: NCT06165302
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn how exercise intervention affects circulating tumor cells (CTC) in men with advanced prostate cancer. The primary objective is to determine if an exercise intervention decreases CTCs in men with advanced prostate cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Men with metastatic prostate adenocarcinoma
- Currently taking androgen deprivation therapy alone or with an oral androgen axis inhibitor (abiraterone, enzalutamide, darolutamide, or apalutamide...
- Elevated (PSA \> 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
- Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
- CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.
You likely can't join if
- Small cell carcinoma of the prostate
- Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
- Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain
- Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
- Bone metastases in spine or long bones which, in the eye of the treating physician require referral to radiation oncology or surgery for management...
- Significant cardiovascular disease or concurrent illness that would make exercise intervention for 12 weeks unsafe. If there is significant...
See the full eligibility criteria
- Men with metastatic prostate adenocarcinoma
- Currently taking androgen deprivation therapy alone or with an oral androgen axis inhibitor (abiraterone, enzalutamide, darolutamide, or apalutamide are permitted) and have been on treatment for at least 3 months
- Elevated (PSA \> 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
- Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
- CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.
- If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status \<=1
- Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)
- Age \<=80 years
- Small cell carcinoma of the prostate
- Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
- Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain
- Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
- Bone metastases in spine or long bones which, in the eye of the treating physician require referral to radiation oncology or surgery for management due to risk of fracture
- Significant cardiovascular disease or concurrent illness that would make exercise intervention for 12 weeks unsafe. If there is significant cardiovascular disease and the participant is under the care of a cardiologist...
- Major surgery within the past 4 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, 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.