Phase 1 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:

(Note: This trial has multiple parts with different requirements. The trial site will determine which part, if any, a person may be considered for.)

General requirements that apply to all parts:

• People diagnosed with prostate cancer that has spread to other parts of the body and is no longer responding to hormone-reducing treatments (confirm with trial site which specific treatments count).
• People who have either had surgical removal of both testicles or are currently receiving ongoing hormone-suppressing therapy (such as a GnRH agonist or antagonist injection).
• People with very low testosterone levels in the blood (below a specific threshold that the trial site can confirm).
• People whose cancer is confirmed to be getting worse, shown by rising PSA levels on at least two tests taken at least one week apart, new spots on a bone scan, or growth of tumours on imaging.
• People who are generally active and able to care for themselves, with only mild limitations on physical activity (a score of 0 or 1 on a standard doctor-assessed fitness scale).
• People with a life expectancy of at least 3 months.
• People with blood counts, kidney function, liver function, heart function, and lung function that meet specific minimum levels as measured by blood tests and scans (confirm exact thresholds with trial site).

Part 1, 2, 5, and 7 — additional requirements:

• People whose cancer has stopped responding to at least one specific hormone-blocking drug (such as abiraterone, enzalutamide, apalutamide, or darolutamide), and who have also received at least one but no more than two rounds of taxane chemotherapy — or who have been assessed by their doctor as medically unsuitable for taxane chemotherapy, or who have actively declined it. A qualifying taxane course means at least 2 treatment cycles.

Part 3 — additional requirements:

• People who have received none, one, or two prior hormone-blocking drug treatments (in any stage of their prostate cancer), and who are medically unsuitable for taxane chemotherapy or have actively declined it (unless taxane was given earlier when the cancer was still hormone-sensitive).
• People who have received no prior experimental treatments for their metastatic disease.

Parts 4A, 4B, and 7 — additional requirements:

• People who have received none, one, or two prior hormone-blocking drug treatments, and no more than one taxane regimen given when the cancer was still hormone-sensitive.
• For Part 4A: people planning to receive abiraterone acetate for the first time (confirm with trial site).
• For Part 4B: people planning to receive enzalutamide for the first time (confirm with trial site).

Part 6 — additional requirements:

• People whose cancer progressed on exactly one prior hormone-blocking drug (enzalutamide, apalutamide, or darolutamide only — not abiraterone).
• People who have not received chemotherapy for their castration-resistant prostate cancer (up to 6 cycles of docetaxel given when the cancer was still hormone-sensitive is acceptable).
• People who have at least one tumour that can be measured on a CT scan or MRI at the start of the study.

Part 3 Retreatment group — additional requirements:

• People who previously participated in Part 3 of this trial, showed a meaningful response to the study drug AMG 509, did not stop the initial treatment due to side effects, and whose cancer has since progressed within 12 months of finishing that initial treatment course.
• People willing to have a fresh tumour biopsy before starting the additional course of treatment, if their doctor considers it safe and feasible.

Who may not be able to join:

• People whose prostate cancer is a specific rare type (such as pure small cell, neuroendocrine carcinoma, or any type other than adenocarcinoma).
• People who have had radiation therapy within 4 weeks before the first dose (or local/targeted radiation within 2 weeks before the first dose).
• People with untreated cancer spread to the brain or the lining of the brain or spinal cord. People with previously treated brain metastases may be considered if imaging shows improvement and no new progression (confirm with trial site).
• People who have had major surgery within 4 weeks before the first dose.
• People with signs of an active, uncontrolled infection within 7 days before the first dose (minor infections that are responding to treatment may be acceptable — confirm with trial site).
• People with a confirmed history of autoimmune disease or any condition that requires long-term or permanent suppression of the immune system.
• People with a history of a serious blood clot in an artery (such as a stroke or TIA) within the past 12 months, or a blood clot in a vein (such as a pulmonary embolism or deep vein thrombosis) within the past 6 months unless stable on blood-thinning medication (confirm with trial site).
• People who have had a heart attack or significant heart failure within the past 12 months (certain exceptions may apply — confirm with trial site).
• People who have received any anti-cancer treatment or immunotherapy within 4 weeks before the first dose (ongoing hormone-suppressing injections are generally excluded from this restriction — confirm with trial site).
• People who have received a specific type of radioactive prostate-targeting therapy (PSMA radionuclide therapy) within 2 months before joining (shorter time restrictions may apply in some parts — confirm with trial site). Parts 3 and 4 do not allow this prior treatment at all.
• For Part 3 Retreatment only: people who received any anti-cancer therapy or immunotherapy after completing their initial AMG 509 treatment course (confirm with trial site).

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