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

NCT06060652 | Recruiting

• 1 other identifier: CRO-2023-11
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Oligometastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT

  To verify if a cut-off value of ≥5 CTC/7.5 mL of blood is prognostic of worst outcome in terms of distant progression-free survival (DPFS). Prognostic value will be measured as hazard ratio and relative 95% confidence intervals. DPFS will be defined as the time between the first day of SBRT and the detection at restaging imaging of clinical disease outside the treatment field

  up to 3 years

Secondary Outcomes (21)

• Biochemical-PSF and CTC

  up to 3 years

• Biochemical-PSF and TCR

  up to 3 years

• Identify signatures in cfDNA of prognostic significance in terms of Biochemical-PSF

  up to 3 years

• Distant-PSF and CTC

  up to 3 years

• Distant-PSF and TCR

  up to 3 years

Study Arms (2)

Retrospective cohort

34 OMPC patients enrolled in the ADAPT-CTC trial

Prospective cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OMPC patients undergoing SBRT

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (2)

IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordenone, 33081, Italy

RECRUITING

ASST Spedali Civili

Brescia, Italy

RECRUITING

Study Officials

• Fabio Matrone, MD

  Centro di Riferimento Oncologico (CRO), IRCCS

  PRINCIPAL INVESTIGATOR

• Giulia Brisotto, PhD

  Centro di Riferimento Oncologico di Aviano (CRO)

  PRINCIPAL INVESTIGATOR

• Matteo Turetta, MD

  Centro di Riferimento Oncologico di Aviano (CRO)

  PRINCIPAL INVESTIGATOR

• Fabio Del Ben, MD

  Centro di Riferimento Oncologico di Aviano (CRO)

  PRINCIPAL INVESTIGATOR

• Luca Triggiani, MD

  Asst Degli Spedali Civili Di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Matrone, MD

CONTACT

+ 39 0434 659 724; fabio.matrone@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

IT (2)