Metastatic Prostate CancerPhase 2NCT04031378
Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer
A Phase 2 study testing Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation and Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months in people with Metastatic Prostate Cancer and Prostate Adenocarcinoma, run by Fundacao Champalimaud at 1 site in Portugal.
Trial summary
The present study aims to optimize the use of systemic therapy relative to local tumor ablation in a prospective randomized clinical trial and to validate the existence and characterize the clinical and pathology phenotype of oligometastatic (OM) prostate cancer (OM-PCa). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation and Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2019to 1 Nov 2022
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic confirmation of adenocarcinoma of the prostate by biopsy confirmed by internal review;
- 68Ga-PSMA or 18F-Choline PET/CT evidence of limited non-visceral (1-3 detectable foci) M1a-b metastases
- All detectable lesions must be considered amenable for SDRT
- Life expectancy > 12 months
- EGOG Performance Status 0-1
- Normal bone marrow functions as defined below: Hemoglobin ≥ 9 g/dl; Absolute Neutrophil count (ANC) ≥1500/ μl; Platelets ≥ 100,000 / μl
- Signed study specific informed consent form
Who cannot join
- Overt polymetastatic disease (≥ 4 lesions or any visceral lesion) as shown by 68Ga-PSMA or 18F-Choline PET/CT
- Previous radiation therapy for OM deposits
- ECOG Performance status ≥2
- Severe, active co-morbidity
- Significant psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Study to Ablate Oligometastatic Prostate Cancer by Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy and to Characterize Its Molecular Phenotype
The present study aims to optimize the use of systemic therapy relative to local tumor ablation in a prospective randomized clinical trial and to validate the existence and characterize the clinical and pathology phenotype of oligometastatic (OM) prostate cancer (OM-PCa).
For local tumor ablation we propose to use the novel non-invasive and highly effective technique of Image-Guided Single Dose Radiotherapy (SDRT), which we showed is capable of conferring long-term local relapse-free rates in ≥ 90% of metastatic PCa lesions. Concomitantly, we will develop, validate and implement a diagnostic algorithm for OM-PCa and functionally characterize Prostate Cancer Stem Cells (pCSCs) from human samples to correlate their molecular phenotypes with tumor response to treatment. The long-term aim is to define the indications, standardization of treatment protocols and outcome for OM-PCa. Response assessment will be via local control, metastasis-free survival and overall survival rates. Cases displaying the clinical OM phenotype, as disclosed via long-term disease remission following tumor ablation, will represent the basis to identify the molecular signatures of OM-PCa. These signatures will be used to develop and validate an algorithm to predict the OM phenotype upfront and define the treatment strategy that may lead to cure.
Read the detailed description
Since a systemic therapy alone is incapable of permanently ablating metastatic prostate cancer (mPCa) lesions, we have designed this clinical trial to explore whether its combination with radiation ablation of low volume (≤3 detectable lesions) mPCa, using the novel and highly effective single dose radiotherapy (SDRT), will render cure of a subset of currently incurable mPCa, as achievable in other tumors at the so-called oligometastatic (OM) phase of tumor progression. Whether OM-PCa does, in fact, exist and whether it can be cured has never been systematically researched. The recent introduction of advanced diagnostic and therapeutic platforms provide new tools to address the OM paradigm in mPCa. For example, while the identification mPCa lesions is still challenging, 18F-Choline and 68Ga-Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography with Computed Tomography (PET/CT) are emerging as effective modalities for the identification of low volume metastases with a pooled sensitivity and specificity exceeding 85%. Hence, the focus of this project is to use modern diagnostic and therapeutic approaches to detect and ablate low tumor-load mPCa lesions, hypothesizing that a subset these tumors will be detected and treated at the OM phase, and may be cured. We propose that systematic studies of each tumor phenotype and their correlation with clinical outcomes will yield not only a validation of the existence of OM-PCa, but will also enable the generation of an algorithm that predicts the OM phenotype upfront and optimizes the treatment strategy.
- Being tested
- Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation, Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months
- Keywords
- Single Dose Radiotherapy, Systemic Therapy, IGRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observationRadiation
SBRT to a single dose of 24 Gy to up to 3 sites
Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 monthsDrug
SBRT 24 Gy to up to 3 nsites, followed by by systemic therapy based on phenotype.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation using PET/CT imaging studies every 6 months Receives: Radiation: Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation |
| B | Experimental | Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months stratified by whether disease is castrate-sensitive (mCS-PCa) or castrate-resistant (mCR-PCa) Receives: Drug: Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with post-treatment abnormal laboratory values (PSA relapse)
Comparison of freedom from biochemical relaps over a 5 year time frame
Measured: Participants should be followed continuously, for the duration of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Greco, MD, Fundacao Champalimaud
- Investigators
- Carlo Greco, M.D., Principal investigator, Champalimaud Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031378
- Sponsor's protocol ID
- PRELUDE
- Status last verified
- Jul 2019
- First submitted
- 16 Jan 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study to Ablate Oligometastatic Prostate Cancer by Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy and to Characterize Its Molecular Phenotype
- ClinicalTrials.gov ID
- NCT04031378
- Acronym / sponsor ID
- PRELUDE
- Keywords
- Single Dose Radiotherapy, Systemic Therapy, IGRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 24 Jul 2019 (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.
The present study aims to optimize the use of systemic therapy relative to local tumor ablation in a prospective randomized clinical trial and to validate the existence and characterize the clinical and pathology phenotype of oligometastatic (OM) prostate cancer (OM-PCa).
For local tumor ablation we propose to use the novel non-invasive and highly effective technique of Image-Guided Single Dose Radiotherapy (SDRT), which we showed is capable of conferring long-term local relapse-free rates in ≥ 90% of metastatic PCa lesions. Concomitantly, we will develop, validate and implement a diagnostic algorithm for OM-PCa and functionally characterize Prostate Cancer Stem Cells (pCSCs) from human samples to correlate their molecular phenotypes with tumor response to treatment. The long-term aim is to define the indications, standardization of treatment protocols and outcome for OM-PCa. Response assessment will be via local control, metastasis-free survival and overall survival rates. Cases displaying the clinical OM phenotype, as disclosed via long-term disease remission following tumor ablation, will represent the basis to identify the molecular signatures of OM-PCa. These signatures will be used to develop and validate an algorithm to predict the OM phenotype upfront and define the treatment strategy that may lead to cure.
Detailed description
Since a systemic therapy alone is incapable of permanently ablating metastatic prostate cancer (mPCa) lesions, we have designed this clinical trial to explore whether its combination with radiation ablation of low volume (≤3 detectable lesions) mPCa, using the novel and highly effective single dose radiotherapy (SDRT), will render cure of a subset of currently incurable mPCa, as achievable in other tumors at the so-called oligometastatic (OM) phase of tumor progression. Whether OM-PCa does, in fact, exist and whether it can be cured has never been systematically researched. The recent introduction of advanced diagnostic and therapeutic platforms provide new tools to address the OM paradigm in mPCa. For example, while the identification mPCa lesions is still challenging, 18F-Choline and 68Ga-Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography with Computed Tomography (PET/CT) are emerging as effective modalities for the identification of low volume metastases with a pooled sensitivity and specificity exceeding 85%. Hence, the focus of this project is to use modern diagnostic and therapeutic approaches to detect and ablate low tumor-load mPCa lesions, hypothesizing that a subset these tumors will be detected and treated at the OM phase, and may be cured. We propose that systematic studies of each tumor phenotype and their correlation with clinical outcomes will yield not only a validation of the existence of OM-PCa, but will also enable the generation of an algorithm that predicts the OM phenotype upfront and optimizes the treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observationSingle Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation using PET/CT imaging studies every 6 months |
| B | Experimental | Drug: Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 monthsSingle Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months stratified by whether disease is castrate-sensitive (mCS-PCa) or castrate-resistant (mCR-PCa) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic confirmation of adenocarcinoma of the prostate by biopsy confirmed by internal review;
- 68Ga-PSMA or 18F-Choline PET/CT evidence of limited non-visceral (1-3 detectable foci) M1a-b metastases
- All detectable lesions must be considered amenable for SDRT
- Life expectancy > 12 months
- EGOG Performance Status 0-1
Key exclusion criteria (5 listed)
- Overt polymetastatic disease (≥ 4 lesions or any visceral lesion) as shown by 68Ga-PSMA or 18F-Choline PET/CT
- Previous radiation therapy for OM deposits
- ECOG Performance status ≥2
- Severe, active co-morbidity
- Significant psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observationSBRT to a single dose of 24 Gy to up to 3 sites | Radiation | A |
| Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 monthsSBRT 24 Gy to up to 3 nsites, followed by by systemic therapy based on phenotype. | Drug | B |
Primary outcome
Number of participants with post-treatment abnormal laboratory values (PSA relapse)
Time frame: Participants should be followed continuously, for the duration of 5 years
Comparison of freedom from biochemical relaps over a 5 year time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
Carlo Greco, M.D. principal investigator
Champalimaud Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation and Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months in people with Metastatic Prostate Cancer and Prostate Adenocarcinoma, run by Fundacao Champalimaud at 1 site in Portugal.
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 7 inclusion and 5 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Manuela Seixas (+351 965289072, manuela.seixas@fundacaochampalimaud.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with post-treatment abnormal laboratory values (PSA relapse) (time frame: Participants should be followed continuously, for the duration of 5 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 24 Jul 2019.