Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with prostate cancer that has spread to 1 to 3 areas in the body (with no symptoms from those spread areas), where each affected area is no larger than 5.0 cm or 250 cm³, confirmed by a CT, MRI, or whole-body MRI scan.
• People whose PSMA-PET/CT scan (a specialised nuclear medicine scan) shows results that match the areas identified on their CT or MRI scan, with a specific scan reading (SUV max) of 3 or higher.
• People whose primary prostate cancer was treated with surgery and/or radiation, including those who had follow-up radiation to the prostate bed or pelvis area.
• People with a confirmed tissue diagnosis of prostate cancer (from either the original tumour or a spread site).
• People with a PSA level between 0.2 and 50 ng/mL and a testosterone level of 125 ng/dL or higher.
• People whose PSA level is doubling in less than 15 months since their cancer returned.
• People who are either medically unable to have hormone therapy (ADT) or who have chosen not to have it.
• People who may have had hormone therapy (ADT) or other systemic treatments in the past as part of their original prostate cancer treatment or alongside salvage radiation.
• People aged 18 or older.
• People who understand the study's purpose, are willing to take part, and are able to sign a consent form.
• People who are reasonably active and able to care for themselves, as measured by a standard medical scale (ECOG performance status of 0, 1, or 2) (confirm with trial site).
• People with a life expectancy of at least 6 months.
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning adequately, including sufficient white blood cell, neutrophil, and platelet counts, and normal bilirubin, liver enzyme, and creatinine levels (confirm with trial site for exact values).
• People who are willing and able to use two effective forms of contraception — including a condom — during the treatment period and for 6 months after the last dose, and who agree not to donate sperm for at least 6 months after their last dose.

Who may not be able to join:

• People who have had more than 3 years of hormone therapy (ADT) in total, or whose most recent hormone therapy was less than 6 months before enrolment.
• People whose PSMA-PET/CT scan was done more than 3 months ago.
• People who have, or are at risk of developing, spinal cord compression.
• People whose cancer is suspected to have spread to the lungs or liver.
• People who have a bone metastasis in a femur (thigh bone).
• People who have previously had radiation treatment to any of the sites where the cancer has spread.
• People who have received chemotherapy or radiotherapy within the past 4 weeks (or 6 weeks for certain specific chemotherapy drugs), or who are still experiencing side effects from earlier treatment.
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days.
• People whose doctor believes that taking part in this trial would not be in their best interest, for any reason.
• People with cancer that has spread to the brain.
• People who have had a serious allergic reaction to substances chemically similar to the study drug (177-Lu-PSMA-I&T).
• People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People who are unable to lie flat during the radiation treatment used in this study (called SABR).
• People who have had another cancer within the past 3 years (except previously treated basal cell skin cancer).
• People known to have HIV, whether or not they have symptoms.

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