PSMA Response in Metastasized Hormone Sensitive Prostate Cancer

Launched by RODERICK VAN DEN BERGH · Dec 3, 2021

Keywords

ClinConnect Summary

This clinical trial, called "PSMA Response in Metastasized Hormone Sensitive Prostate Cancer," is studying how well certain treatments work in men who have been recently diagnosed with advanced prostate cancer that is sensitive to hormonal therapy. Specifically, the trial looks at how the cancer responds to a type of imaging called PSMA-PET/CT after starting treatment with hormonal therapy and other upfront therapies like apalutamide or abiraterone.

To participate, men must be over 18 years old and have a confirmed diagnosis of prostate cancer that has spread to other parts of the body (stage M1). They should also be starting hormonal therapy and have more than three areas of cancer spread, as seen on the imaging tests. Participants will be asked to provide written consent and will need to be in good mental and physical health to ensure they can handle the study. Those who join the trial can expect to undergo imaging tests and receive standard cancer treatments while being closely monitored for their response to the therapy. It's important to note that those with other active cancers or serious unrelated health issues may not be eligible for this study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Men \>18 years of age.
• • Mentally competent and understanding of benefits and potential burden of the study.
• • Written and signed informed consent.
• • Histological confirmed diagnosis of adenocarcinoma of the prostate.
• • Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
• • Indicated to start on upfront therapy (apalutamide or abiraterone).
• • Any initial PSA.
• • Any Gleason score.
• • Any T-stage.
• • Any N-stage.
• • Stage M1, with multiple / high volume metastasis: More than three (\>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent.
• Exclusion Criteria:
• • Concomitant malignancy (except from BCC of the skin).
• • History of prior diagnosed or treated PCa.
• • Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
• • Any known allergy for the upfront therapy.
• • Any known allergy for LHRH agonist or antagonist.