Assessing PSMA-PET/CT response in men with advanced prostate cancer

Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging

This study is testing if early scans can help doctors see how well treatment is working for men with advanced prostate cancer who are starting hormone therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: UMC Utrecht (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Amersfoort and 3 other locations)
• Trial ID: NCT05161728 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of early response measurements using PSMA-PET/CT in men newly diagnosed with metastasized hormone-sensitive prostate cancer who are starting standard hormonal therapy. Participants will receive either upfront chemotherapy or androgen-receptor targeted agents, with the goal of personalizing treatment based on their response. The primary focus is to determine how well these early response measurements can predict the time until the cancer becomes castration-resistant. This is a prospective, single-arm, open-label observational study involving patients with multiple metastatic lesions.

Who should consider this trial

Good fit: Ideal candidates are men over 18 years old with newly diagnosed, histologically confirmed prostate cancer and more than three metastatic lesions.

Not a fit: Patients with a history of prior prostate cancer or concomitant malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment options for men with advanced prostate cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise in using imaging techniques like PSMA-PET/CT for treatment response assessment, indicating potential for success in this approach.

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.

Where this trial is running

Amersfoort and 3 other locations

• Meander MC — Amersfoort, Netherlands (RECRUITING)
• Canisius-Wilhelmina Ziekenhuis — Nijmegen, Netherlands (RECRUITING)
• St Antonius Ziekenhuis — Utrecht, Netherlands (RECRUITING)
• UMC Utrecht — Utrecht, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Roderick van den Bergh, MD PhD

Conditions: Prostate Cancer, psma, response, metastasis, upfront