Status:
RECRUITING
Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Oligometastatic Prostate Cancer
Eligibility:
MALE
18+ years
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 res...
Detailed Description
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 res...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Retrospective cohort
- \>18 years old;
- Patients previously included in the ADAPT-CTC trial
- Signing written informed consent
- 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
- 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
Key Trial Info
Start Date :
May 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 11 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06060652
Start Date
May 11 2023
End Date
May 11 2026
Last Update
September 29 2023
Active Locations (2)
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1
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordenone, Italy, 33081
2
ASST Spedali Civili
Brescia, Italy