Management of Oligometastatic Prostate Cancer Using Biomarkers
Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
Centro di Riferimento Oncologico - Aviano · NCT06060652
This study is testing if analyzing blood samples can help doctors better understand and manage prostate cancer that has spread to a few places in the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centro di Riferimento Oncologico - Aviano (other) |
| Locations | 2 sites (Aviano, Pordenone and 1 other locations) |
| Trial ID | NCT06060652 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the prognostic stratification of patients with oligometastatic prostate cancer (OMPC) by analyzing various biomarkers. It utilizes liquid biopsy techniques to assess tumor-derived analytes and circulating immune cells from blood samples, which can provide insights into the disease's heterogeneity and the host's immune response. The goal is to identify prognostic and predictive biomarkers that can help monitor treatment responses and resistance. By combining these analyses, the study aims to address the urgent need for effective prognostic tools in OMPC management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with histologically confirmed acinar adenocarcinoma of the prostate and hormone-sensitive oligometastatic disease.
Not a fit: Patients with non-hormone-sensitive prostate cancer or those with more than three metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with oligometastatic prostate cancer.
How similar studies have performed: Preliminary results from other studies suggest that similar biomarker analyses have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Retrospective cohort * \>18 years old; * Patients previously included in the ADAPT-CTC trial * Signing written informed consentInclusion Criteria: Prospective cohort * \>18 years old * Histologic confirmation (primary or metastatic tumor) of Acinar Adenocarcinoma of Prostate * Hormone-sensitive OMPC defined as ≤3 metachronous metastases (bone and/or lymph node) detected within the past 6 months with Choline/PSMA PET-CT following prostate specific antigen (PSA) rising after primary treatment (surgery and/or radiotherapy) with curative intent as defined by European Association of Urology criteria (EAU). * Controlled primary tumor * Prior salvage treatment to the primary prostate cancer is allowed. * PSA ≤ 50 ng/mL * Testosterone ≥ 0.5 ng/mL * ADT associated to the primary treatment concluded more than 6 months prior to the enrollment. * Patients eligible for a course of SBRT on bone and/or lymph node metastatic sites * Patients must have a life expectancy ≥ 12 months and an ECOG performance status ≤ 2 * Patients must have normal organ and marrow function defined as: * Leukocytes ≥2000/µL * Absolute Neutrophil Count ≥1000/µL * Platelets ≥50000/µL * Patients amenable to understand and sign written informed consent documents Exclusion Criteria: Prospective cohort * Spinal cord compression or impending spinal cord compression. * Suspected pulmonary and/or liver metastases * Patient receiving any other investigational agents * Patient is participating in a concurrent treatment protocol * Prior treatments for hormone-sensitive OMPC * Serum creatinine \> 3 times the upper limit of normal. * Total bilirubin \> 3 times the upper limit of normal. * Liver Transaminases \> 5-times the upper limit of normal. * Unable to lie flat during or tolerate PET/CT or SBRT. * Previous history of cancer other than non-melanoma skin cancer in the last 5 years * Traumatic bone events in the 4 weeks before PET
Where this trial is running
Aviano, Pordenone and 1 other locations
- IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano — Aviano, Pordenone, Italy (RECRUITING)
- ASST Spedali Civili — Brescia, Italy (RECRUITING)
Study contacts
- Principal investigator: Fabio Matrone, MD — Centro di Riferimento Oncologico (CRO), IRCCS
- Study coordinator: Fabio Matrone, MD
- Email: fabio.matrone@cro.it
- Phone: + 39 0434 659 724
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: Oligometastatic Prostate Cancer