Prostate CancerPET-MaN-enzaNCT05539300
PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide
A study testing PSMA-PET/CT response evaluation in people with Prostate Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-PET/CT response evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 1 Jan 2026
- Phase
- Interventional
- 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
- Men >18 years of age.
- Mentally competent and understanding of benefits and potential burden of the study.
- Written and signed informed consent.
- Histological confirmed diagnosis of adenocarcinoma of the prostate.
- Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
- Indicated to start on upfront therapy (enzalutamide).
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- Any initial PSA.
- Any Gleason score.
- Any T-stage.
- Any N-stage.
- Stage M1, with multiple / high volume metastasis: More than three (>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent.
Who cannot join
- Concomitant malignancy (except from BCC of the skin).
- History of prior diagnosed or treated PCa.
- Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
- Any known allergy for the upfront therapy.
- Any known allergy for LHRH agonist or antagonist.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Roderick van den Bergh
Utrecht, 3583VS
Roderick VD Bergh, 0623456800, roodvdb@hotmail.com
About this study
Official title: Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging - Enzalutamide
PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
Read the detailed description
Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed.
Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.
Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study.
Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (enzalutamide) in addition to standard hormonal therapy.
Main study parameters/endpoints:
Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria. Primary endpoint: Time to development of CRPC. Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:
Patients will be treated according to standard of care, including baseline PSMA-PET/CT. The timing of follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at biochemical or clinical signs of disease progression, one PSMA-PET/CT will be performed after two months of hormonal therapy, one PSMA-PET/CT will be performed after two months of upfront therapy. Each PSMA-PET/CT scan will require an extra visit (2-3 hours) and a limited radiation burden after intravenous injection of PSMA. The additional information from the standardized follow-up PSMA-PET/CT scans will not be used for clinical decision-making.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-PET/CT response evaluation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-PET/CT response evaluationDiagnostic test
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy
| Study group | Role | What they receive |
|---|---|---|
| PSMA response evaluation arm | Experimental | PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy Receives: Diagnostic Test: PSMA-PET/CT response evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRPC
Development of castration-resistant prostate cancer
Measured: 12-24 months after start
Secondary outcomes (1)
Second line therapy
Initiation of second line therapy
Measured: 12-24 months after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Mar 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick van den Bergh, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539300
- Sponsor's protocol ID
- NL81959.041.22
- Acronym
- PET-MaN-enza
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging - Enzalutamide
- ClinicalTrials.gov ID
- NCT05539300
- Acronym / sponsor ID
- PET-MaN-enza / NL81959.041.22
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 14 Sep 2022 (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.
PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
Detailed description
Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed.
Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.
Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study.
Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (enzalutamide) in addition to standard hormonal therapy.
Main study parameters/endpoints:
Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria. Primary endpoint: Time to development of CRPC. Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:
Patients will be treated according to standard of care, including baseline PSMA-PET/CT. The timing of follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at biochemical or clinical signs of disease progression, one PSMA-PET/CT will be performed after two months of hormonal therapy, one PSMA-PET/CT will be performed after two months of upfront therapy. Each PSMA-PET/CT scan will require an extra visit (2-3 hours) and a limited radiation burden after intravenous injection of PSMA. The additional information from the standardized follow-up PSMA-PET/CT scans will not be used for clinical decision-making.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA response evaluation arm | Experimental | Diagnostic Test: PSMA-PET/CT response evaluationPSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men >18 years of age.
- Mentally competent and understanding of benefits and potential burden of the study.
- Written and signed informed consent.
- Histological confirmed diagnosis of adenocarcinoma of the prostate.
- Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
Key exclusion criteria (5 listed)
- Concomitant malignancy (except from BCC of the skin).
- History of prior diagnosed or treated PCa.
- Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
- Any known allergy for the upfront therapy.
- Any known allergy for LHRH agonist or antagonist.
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 |
|---|---|---|
| PSMA-PET/CT response evaluationPSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy | Diagnostic test | PSMA response evaluation arm |
Primary outcome
CRPC
Time frame: 12-24 months after start
Development of castration-resistant prostate cancer
1 secondary outcome
Second line therapy
Time frame: 12-24 months after start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-PET/CT response evaluation in people with Prostate Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 11 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 9 Jan 2024. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRPC (time frame: 12-24 months after start). 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 9 Jan 2024.