Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)

Centro di Riferimento Oncologico - Aviano

Status

Enrolling

Conditions

Oligometastatic Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT06060652

CRO-2023-11

Details and patient eligibility

About

Currently, despite the advent of next-generation imaging has improved the detection of Oligometastatic prostate cancer (OMPC), prognostic biomarkers able to stratify patients and monitor treatment response are lacking and urgently needed. Mounting evidence suggests that molecular profiling of the disease and host immune activity evaluation can reveal OMPC heterogeneity and address the above unmet clinical need.

This study aims at combining the analysis of several biomarkers to improve the prognostic stratification of OMPC patients

Full description

Liquid biopsy, defined as the sampling and analysis of tumor-derived analytes [i.e.: circulating tumor cells (CTCs), or circulating tumor DNA (ctDNA)] from blood, represents a powerful tool to assess in real-time the evolving landscape of cancer, identify prognostic and predictive biomarkers and detect resistance to therapies in several cancers, including Prostate Cancer (PC).

Additionally, the same blood sample allows the profiling of tumor-associated components, such as circulating immune cells, which may give clues at the systemic level about the dynamic and complex host-tumor interaction. It is non-invasive, easily repeatable, and cost-effective. In this regard, preliminary results derived from clinical studies indicate that the analysis of tumor material circulating in peripheral blood, combined with the study of the host immune response might be pivotal. This study aims at combining the analysis of several biomarkers, associated with both tumor (CTC and cfDNA) and host (TCR), with a micro-invasive approach, such as liquid biopsy, to improve the prognostic stratification of OMPC patients compared to conventional laboratory test (PSA) and imaging exams (Choline- or PSMA-PET imaging).

Enrollment

104 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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