Oligometastatic Prostate CancerPROMETEONCT06060652
Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
An observational study of Oligometastatic Prostate Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer
- How many people
- 104 participants
- Where
- 2 sitesItaly
- Study dates
- 11 May 2023to 11 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: OMPC patients undergoing SBRT
Who may be able to join
- Retrospective cohort
- >18 years old;
- Patients previously included in the ADAPT-CTC trial
- Signing written informed consentInclusion Criteria:
- Prospective cohort
- >18 years old
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordenone, 33081
Fabio Matrone, MD, +390434659724, fabio.matrone@cro.it
- Recruiting
ASST Spedali Civili
Brescia
Luca Triggiani, MD
About this study
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
Read the 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 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
- Oligometastatic Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Secondary outcomes (21)
Biochemical-PSF and CTC
Evaluate the relation between CTC number and its variation and biochemical PFS defined as the time between the first day of SBRT to the PSA increase ≥ 25% and ≥ 2 ng/mL if PSA was ≥ 2 ng/mL from baseline, or a PSA increase ≥ 25% if PSA was < 2 ng/mL.
Measured: up to 3 years
Biochemical-PSF and TCR
Evaluate the relation between TCR values and biochemical PFS defined as the time between the first day of SBRT to the PSA increase ≥ 25% and ≥ 2 ng/mL if PSA was ≥ 2 ng/mL from baseline, or a PSA increase ≥ 25% if PSA was < 2 ng/mL.
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Biochemical-PSF
Association between the presence of a combination of specific tumour mutations detected in cfDNA and Biochemical-PSF defined as the time between the first day of SBRT to the PSA increase ≥ 25% and ≥ 2 ng/mL if PSA was ≥ 2 ng/mL from baseline, or a PSA increase ≥ 25% if PSA was < 2 ng/mL.
Measured: up to 3 years
Distant-PSF and CTC
Evaluate the relation between CTC number and its variation and distant PFS defined as the time between the first day of SBRT to the detection at restaging imaging of clinical disease outside the treatment field obtained after biochemical progression
Measured: up to 3 years
Distant-PSF and TCR
Evaluate the relation between TCR values and distant PFS defined as the time between the first day of SBRT to the detection at restaging imaging of clinical disease outside the treatment field obtained after biochemical progression
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Distant-PSF
association between the presence of a combination of specific tumour mutations detected in cfDNA and distant PFS defined as the time between the first day of SBRT to the detection at restaging imaging of clinical disease outside the treatment field obtained after biochemical progression
Measured: up to 3 years
Local control and CTC
Evaluate the relation between CTC number and its variation and local control defined as no evidence of disease in the treatment field at restaging imaging obtained after biochemical progression
Measured: up to 3 years
Local control and TCR
Evaluate the relation between TCR values and local control defined as no evidence of disease in the treatment field at restaging imaging obtained after biochemical progression
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Local control
association between the presence of a combination of specific tumour mutations detected in cfDNA and local control defined as no evidence of disease in the treatment field at restaging imaging obtained after biochemical progression
Measured: up to 3 years
ADT-free survival and CTC
Evaluate the relation between CTC number and its variation and ADT-FS defined as time between the first day of SBRT to the start of palliative ADT
Measured: up to 3 years
ADT-free survival and TCR
Evaluate the relation between TCR values and ADT-FS defined as time between the first day of SBRT to the start of palliative ADT
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of ADT-free survival
association between the presence of a combination of specific tumour mutations detected in cfDNA and ADT-FS defined as time between the first day of SBRT to the start of palliative ADT
Measured: up to 3 years
time to castration resistant Prostate Cancer and CTC
Evaluate the relation between CTC number and its variation and TTCR defined as the time between the first day of SBRT to the PSA ≥ 2 ng/mL and Testosterone levels < 0.5 ng/mL
Measured: up to 3 years
time to castration resistant Prostate Cancer and TCR
Evaluate the relation between TCR values and TTCR defined as the time between the first day of SBRT to the PSA ≥ 2 ng/mL and Testosterone levels < 0.5 ng/mL
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of time to castration resistant Prostate Cancer
association between the presence of a combination of specific tumour mutations detected in cfDNA and TTCR defined as the time between the first day of SBRT to the PSA ≥ 2 ng/mL and Testosterone levels < 0.5 ng/mL
Measured: up to 3 years
Overall survival and CTC
Evaluate the relation between CTC number and its variation and OS defined as the time between the first day of SBRT to the time of death.
Measured: up to 3 years
Overall survival and TCR
Evaluate the relation between TCR values and OS defined as the time between the first day of SBRT to the time of death.
Measured: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Overall survival
association between the presence of a combination of specific tumour mutations detected in cfDNA and OS defined as the time between the first day of SBRT to the time of death.
Measured: up to 3 years
TCR values
Median of TCR diversity, clonality and fold change before and after SBRT
Measured: up to 3 years
cfDNA
Frequency of selected tumour mutations in cfDNA
Measured: up to 3 years
prognostic value of the combination of different biomarkers
difference in distant-PFS probability between subgroups of patients carrying different combination of circulating biomarkers. Distant PFS will be defined as the time between the first day of SBRT to the detection at restaging imaging of clinical disease outside the treatment field obtained after biochemical progression
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start11 May 2023
- Primary completion11 May 2026 (estimated)
- Study completion11 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Matrone, MD, Principal investigator, Centro di Riferimento Oncologico (CRO), IRCCSGiulia Brisotto, PhD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)Matteo Turetta, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)Fabio Del Ben, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)Luca Triggiani, MD, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060652
- Sponsor's protocol ID
- CRO-2023-11
- Acronym
- PROMETEO
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
- ClinicalTrials.gov ID
- NCT06060652
- Acronym / sponsor ID
- PROMETEO / CRO-2023-11
- Conditions
- Oligometastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 11 May 2026 (estimated)
- Study completion
- 11 May 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- OMPC patients undergoing SBRT
Key inclusion criteria (20 listed)
- Retrospective cohort
- >18 years old;
- Patients previously included in the ADAPT-CTC trial
- Signing written informed consentInclusion Criteria:
- Prospective cohort
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT
Time frame: up to 3 years
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
21 secondary outcomes
Biochemical-PSF and CTC
Time frame: up to 3 years
Biochemical-PSF and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Biochemical-PSF
Time frame: up to 3 years
Distant-PSF and CTC
Time frame: up to 3 years
Distant-PSF and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Distant-PSF
Time frame: up to 3 years
Local control and CTC
Time frame: up to 3 years
Local control and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Local control
Time frame: up to 3 years
ADT-free survival and CTC
Time frame: up to 3 years
ADT-free survival and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of ADT-free survival
Time frame: up to 3 years
time to castration resistant Prostate Cancer and CTC
Time frame: up to 3 years
time to castration resistant Prostate Cancer and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of time to castration resistant Prostate Cancer
Time frame: up to 3 years
Overall survival and CTC
Time frame: up to 3 years
Overall survival and TCR
Time frame: up to 3 years
Identify signatures in cfDNA of prognostic significance in terms of Overall survival
Time frame: up to 3 years
TCR values
Time frame: up to 3 years
cfDNA
Time frame: up to 3 years
prognostic value of the combination of different biomarkers
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Matrone, MD principal investigator
Centro di Riferimento Oncologico (CRO), IRCCS
Giulia Brisotto, PhD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO)
Matteo Turetta, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Prostate Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Matrone, MD (+ 39 0434 659 724, fabio.matrone@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.