Clinical trial · Observational
Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
NCT06060652CI-TRIAL-00070077PROMETEOunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- 34 OMPC patients enrolled in the ADAPT-CTC trial
- label
- Prospective cohort
- description
- A minimum sample size of 70 OMPC patients undergoing SBRT must be enrolled in this study to satisfy the study endpoints
Primary outcomes (1)
- measure
- Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT
- timeFrame
- up to 3 years
- description
- 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
Secondary outcomes (21)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.