Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give written consent to participate
• People who have been confirmed through a tissue or cell sample to have prostate adenocarcinoma (a specific type of prostate cancer)
• People who have cancer that has spread to other parts of the body, shown on imaging scans, or whose cancer has returned or stopped responding after surgery or radiation to the prostate
• People whose cancer appears stable or improving, shown by a stable or improving PSA level over at least 2 months
• People who have been on hormone-suppressing treatment (via medication or surgical removal of the testicles) for at least 3 months
• People who are also taking abiraterone or enzalutamide alongside their hormone treatment may still be eligible
• People who are expected to remain on hormone-suppressing treatment for at least another 6 months
• People with bone metastases that are not causing symptoms may still be eligible (exercise would be adjusted and monitored)
• People with a general health and activity level rated at ECOG 2 or better (meaning able to care for oneself, though possibly not able to do heavy physical work)
• People who are able to complete a supervised maximum-effort exercise test assessed by a heart specialist
• People with a haemoglobin level of at least 9.0 g/dL, without needing recent transfusions or growth factor support in the 3 months before joining
• People with a platelet count of at least 75,000/uL, without needing recent transfusions or growth factor support in the 3 months before joining
• People who have access to a smartphone running Android or iPhone (iOS) software
• People who can speak and understand English

Who may not be able to join:

• People currently receiving other systemic (whole-body) treatments for prostate cancer beyond what is specifically permitted (GnRH medications, abiraterone, enzalutamide, bisphosphonates, or RANK-ligand inhibitors are allowed)
• People with an existing medical or psychiatric condition that, in the investigator's judgement, could make the exercise program unsafe or make it hard to interpret any side effects
• People who have been unable to walk 400 metres or perform arm, leg, and resistance exercises in the past 3 months
• People who have received chemotherapy within 28 days before joining the study
• People whose bone metastases are causing symptoms
• People currently taking any other experimental or investigational medications
• People who have had radiation therapy or surgery to treat bone metastases
• People with another active and clinically significant cancer other than prostate cancer
• People with a prolonged heart electrical interval (QTc of 450 milliseconds or more) on a pre-entry heart tracing (ECG)
• People with significant heart conditions that could affect exercise safety, including coronary artery disease, a heart attack or blood clot event in the past 6 months, severe or unstable chest pain, a history of serious heart rhythm problems, advanced heart failure (New York Heart Association Class III–IV), or a heart pumping function below 40%
• People with untreated spinal cord compression that is causing symptoms
• People who are currently imprisoned
• People who are being held involuntarily for treatment of a psychiatric or physical illness

Important: Always verify eligibility with the trial site directly before applying.