Evaluating PSMA-PET/CT response in men with advanced prostate cancer receiving enzalutamide
Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging - Enzalutamide
NA · UMC Utrecht · NCT05539300
This study is testing if early results from a special imaging scan can help doctors predict how well men with advanced prostate cancer will respond to a new treatment called enzalutamide.
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 | 1 site (Utrecht) |
| Trial ID | NCT05539300 on ClinicalTrials.gov |
What this trial studies
This study assesses the predictive value of early response measurements on PSMA-PET/CT in men diagnosed with de novo metastasized hormone-sensitive prostate cancer who are starting treatment with enzalutamide alongside standard hormonal therapy. The aim is to personalize treatment choices by determining how early response can predict the time to development of castration-resistant prostate cancer (CRPC). The study is designed as a prospective, single-arm, open-label observational cohort study, focusing on patients with multiple metastatic lesions. By analyzing response data, the study seeks to improve treatment strategies and outcomes for patients.
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 as seen on PSMA-PET/CT.
Not a fit: Patients with a history of prior diagnosed or treated prostate cancer or those with 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 survival rates and quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing imaging response to guide treatment decisions in cancer care.
Eligibility criteria
Show full inclusion / exclusion 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 (enzalutamide). * 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
Utrecht
- Roderick van den Bergh — Utrecht, Netherlands (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer