MedDataX Logo

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

NCT ID: NCT06060652

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2026-05-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oligometastatic Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrospective cohort

34 OMPC patients enrolled in the ADAPT-CTC trial

No interventions assigned to this group

Prospective cohort

A minimum sample size of 70 OMPC patients undergoing SBRT must be enrolled in this study to satisfy the study endpoints

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Retrospective cohort

* \>18 years old;
* Patients previously included in the ADAPT-CTC trial

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabio Matrone, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico (CRO), IRCCS

Giulia Brisotto, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Matteo Turetta, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Fabio Del Ben, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Luca Triggiani, MD

Role: PRINCIPAL_INVESTIGATOR

Asst Degli Spedali Civili Di Brescia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordenone, Italy

Site Status RECRUITING

ASST Spedali Civili

Brescia, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fabio Matrone, MD

Role: CONTACT

Phone: + 39 0434 659 724

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fabio Matrone, MD

Role: primary

Luca Triggiani, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRO-2023-11

Identifier Type: -

Identifier Source: org_study_id