Metastatic Prostate CancerPROMPTNCT04746300
imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS
An observational study of Metastatic Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or platinum-therapy). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Biopsy and Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Feb 2020to Feb 2025
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A total of 600 patients with metastatic castration-resistant prostate cancer with clinical, radiographic or biochemical disease progression may be included in this study. The expected number of patients eligible for the protocol is well above 200 patients per year, including referrals from regional/community hospitals.
Who may be able to join
- Male aged 18 or older with adenocarcinoma of the prostate defined by: Documented histopathology at diagnosis of prostate adenocarcinoma without evidence of predominant or primary neuroendocrine histology.
- Patients with a metastatic tumor site accessible for image-guided biopsy and allowing research analyses for this trial (e.g. biomarker testing by genomic, proteomic or transcriptomic assessment). A waiver can be made for patients presenting with metastatic hormone-sensitive prostate cancer (mHSPC), and no easily accessible tumour for biopsy and suitable primary tissue available for NGS.
- Castration-resistant state (defined as disease progressing despite [chemical] castration per PCWG3 criteria)
- Progressive disease as either
- A rising PSA on minimum 2 serial consecutive measurements
- Radiographic soft tissue progression per RECIST1.1 or bone progression per PCWG3 criteria
Show all 23Show fewer
- Clinical progression
- At least one metastatic lesion present at baseline CT, MRI, 68Ga/18F-PSMA PET or bone scan
- ECOG Performance status 0 to 2
- Serum testosterone on castration level
- Adequate renal function:
- MDRD-GFR ≥ 30 ml/min/1.73m2
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin (Hb) ≥ 5.6 mmol/L
- Adequate liver function:
- Total bilirubin level ≤ 2 institutional upper limit of the normal (ULN)
- Aspartate aminotransferase (ASAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
- Alanine aminotransferase (ALAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
- Estimated life expectancy > 12 months
- Willing and able to comply to the research protocol
- Signed, written informed consent
Who cannot join
- Prior chemotherapy and androgen receptor inhibition therapy related to castration resistant prostate cancer (one line of chemotherapy or androgen receptor inhibition may be given in the hormone-sensitive setting)
- Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer. A waiver may be obtained from the PI in cases where the active malignancy is indolent and believed not to reduce mortality.
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI).
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
- Any condition which, in the opinion of the investigator, would preclude participation in this observational study.
Trial locations and contacts
1 site in 1 country.
Iris Kloots, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud UMC
Nijmegen, Gelderland, 6500HB
Niven Mehra, MD, PhD, niven.mehra@radboudumc.nl
Iris Kloots, MD, iris.kloots@radboudumc.nl
About this study
Official title: imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration-resistant ProsTate Cancer by Next Generation DNA Sequencing (PROMPT-study)
The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or platinum-therapy). The investigators hypothesize that, by doing this early in the disease course (before exhausting standard of care options), it will improve treatment planning, patient outcome, quality of life, and reduce costs.
Read the detailed description
Prostate cancer is a major health problem leading to significant morbidity and mortality in men worldwide. Approved therapies for metastatic castration-resistant prostate cancer (mCRPC) include abiraterone and enzalutamide (targeting the androgen signaling pathway), radium-223 (bone targeting radionuclide therapy), and taxane chemotherapy. Controversy remains on optimal sequencing of available therapeutic agents, and these drugs are still commonly prescribed in a trial-and-error manner. Only a minority of patients receives the full benefit of the anticancer armamentarium, but all experience unnecessary side-effects, quality of life deterioration, and delay in onset to adequate life-prolonging treatment. In addition, the prescription of ineffective drugs and avoidable hospital admissions contribute to the financial burden of health care systems.
In recent years, distinct molecular subsets of prostate cancer have been identified in mCRPC. These molecular defects may guide physicians in proper sequencing of medication and in predicting the individual response more accurately. In previous studies using next-generation sequencing (NGS) mCRPC patients could be grouped into clearly distinct molecular subtypes. Moreover, in these subtypes biomarkers associated with resistance to certain therapies, or biomarkers actually predictive for enhanced response were identified.
In this study the investigators will introduce routine molecular characterization in participants with mCRPC as early as possible in their disease state. Participants will be screened before initiation of second-line treatment, since early identification will maximize clinical and financial benefit. Following screening, participants will be discussed in molecular tumor board and clinical meetings, and stratified to the agent they are most likely to respond to. Translational research is included to identify and validate additional predictive molecular biomarkers.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Biopsy, Blood sample
- Keywords
- mCRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
A biopsy will be taken from metastatic tissue, which will be used for DNA sequencing
Blood sampleProcedure or surgery
Blood samples will be taken for additional translational research
| Study group | Role | What they receive |
|---|---|---|
| Group 1: no sequencing | Participants in this group, for which DNA sequencing could not be reported due to a variety of (quality/technical) reasons, will be treated with standard of care therapy. This group is therefore comparable to patients treated outside the Radboudumc. Receives: Procedure: Biopsy; Procedure: Blood sample | |
| Group 2: no druggable aberration | Participants in this group received a DNA sequencing report identifying no biomarkers to which a logical treatment option can be connected. These participants will also receive standard of care therapy. Receives: Procedure: Biopsy; Procedure: Blood sample | |
| Group 3: allocated to personalized treatment | Participants in this group received a DNA sequencing report which identified presence of a biomarker allowing the participant to be treated with a personalized therapy. This therapy could range from immunotherapy, or PARP inhibitors, to other medication. Receives: Procedure: Biopsy; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsiveness ratio
Ratio of radiographic progression-free survival of personalized treatment or standard of care to the standard last line therapy (PFS-MPT-ratio vs PFS-SOC-ratio)
Measured: Throughout completion of study (estimated 5 years from start)
Secondary outcomes (12)
Efficacy endpoint: ORR
Best objective response rate (ORR) per RECIST1.1 criteria
Measured: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: rPFS
Radiographic progresssion free survival (per RECIST1.1)
Measured: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: PSA response
PSA decline >50% at 12 weeks or later
Measured: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: PSA-PFS
Time to PSA progression (per PCWG3 criteria)
Measured: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: OS
Overall survival capped at 1 year
Measured: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EORTC-QLQ-30
Score of EORTC-QLQ-30 questionnaire
Measured: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EPIC-26
Score of EPIC-26 questionnaire
Measured: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EQ-5D-5L
Score of EQ-5D-5L questionnaire
Measured: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: BIP-SF
Score of BIP-SF questionnaire
Measured: Throughout completion of study (estimated 5 years from start)
Medical Resource Utilization (MRU); nr of lines
Averaged number of lines of standard care per year
Measured: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Medical Resource Utilization (MRU); costs
Averaged costs of standard care per year
Measured: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Medical Resource Utilization (MRU); treatment-related costs
Averaged costs of treatment-related resource utilization (e.g. admissions in ward or ICU) per admission and/or per duration
Measured: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start4 Feb 2020
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VGZ health insurance (NL), Paul Speth Foundation (NL), Radboud Oncology Fund (NL)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746300
- Sponsor's protocol ID
- MOURO41 - PROMPT
- Other IDs
- NL68315.091.19
- Acronym
- PROMPT
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 9 Feb 2021
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration-resistant ProsTate Cancer by Next Generation DNA Sequencing (PROMPT-study)
- ClinicalTrials.gov ID
- NCT04746300
- Acronym / sponsor ID
- PROMPT / MOURO41 - PROMPT
- Conditions
- Metastatic Prostate Cancer
- Keywords
- mCRPC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- VGZ health insurance (NL), Paul Speth Foundation (NL), Radboud Oncology Fund (NL)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 9 Feb 2021 (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 PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or platinum-therapy). The investigators hypothesize that, by doing this early in the disease course (before exhausting standard of care options), it will improve treatment planning, patient outcome, quality of life, and reduce costs.
Detailed description
Prostate cancer is a major health problem leading to significant morbidity and mortality in men worldwide. Approved therapies for metastatic castration-resistant prostate cancer (mCRPC) include abiraterone and enzalutamide (targeting the androgen signaling pathway), radium-223 (bone targeting radionuclide therapy), and taxane chemotherapy. Controversy remains on optimal sequencing of available therapeutic agents, and these drugs are still commonly prescribed in a trial-and-error manner. Only a minority of patients receives the full benefit of the anticancer armamentarium, but all experience unnecessary side-effects, quality of life deterioration, and delay in onset to adequate life-prolonging treatment. In addition, the prescription of ineffective drugs and avoidable hospital admissions contribute to the financial burden of health care systems.
In recent years, distinct molecular subsets of prostate cancer have been identified in mCRPC. These molecular defects may guide physicians in proper sequencing of medication and in predicting the individual response more accurately. In previous studies using next-generation sequencing (NGS) mCRPC patients could be grouped into clearly distinct molecular subtypes. Moreover, in these subtypes biomarkers associated with resistance to certain therapies, or biomarkers actually predictive for enhanced response were identified.
In this study the investigators will introduce routine molecular characterization in participants with mCRPC as early as possible in their disease state. Participants will be screened before initiation of second-line treatment, since early identification will maximize clinical and financial benefit. Following screening, participants will be discussed in molecular tumor board and clinical meetings, and stratified to the agent they are most likely to respond to. Translational research is included to identify and validate additional predictive molecular biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: no sequencing | – | Procedure: Biopsy, Procedure: Blood sampleParticipants in this group, for which DNA sequencing could not be reported due to a variety of (quality/technical) reasons, will be treated with standard of care therapy. This group is therefore comparable to patients treated outside the Radboudumc. |
| Group 2: no druggable aberration | – | Procedure: Biopsy, Procedure: Blood sampleParticipants in this group received a DNA sequencing report identifying no biomarkers to which a logical treatment option can be connected. These participants will also receive standard of care therapy. |
| Group 3: allocated to personalized treatment | – | Procedure: Biopsy, Procedure: Blood sampleParticipants in this group received a DNA sequencing report which identified presence of a biomarker allowing the participant to be treated with a personalized therapy. This therapy could range from immunotherapy, or PARP inhibitors, to other medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 600 patients with metastatic castration-resistant prostate cancer with clinical, radiographic or biochemical disease progression may be included in this study. The expected number of patients eligible for the protocol is well above 200 patients per year, including referrals from regional/community hospitals.
Key inclusion criteria (23 listed)
- Male aged 18 or older with adenocarcinoma of the prostate defined by: Documented histopathology at diagnosis of prostate adenocarcinoma without evidence of predominant or primary neuroendocrine histology.
- Patients with a metastatic tumor site accessible for image-guided biopsy and allowing research analyses for this trial (e.g. biomarker testing by genomic, proteomic or transcriptomic assessment). A waiver can be made for patients presenting with metastatic hormone-sensitive prostate cancer (mHSPC), and no easily accessible tumour for biopsy and suitable primary tissue available for NGS.
- Castration-resistant state (defined as disease progressing despite [chemical] castration per PCWG3 criteria)
- Progressive disease as either
- At least one metastatic lesion present at baseline CT, MRI, 68Ga/18F-PSMA PET or bone scan
Key exclusion criteria (6 listed)
- Prior chemotherapy and androgen receptor inhibition therapy related to castration resistant prostate cancer (one line of chemotherapy or androgen receptor inhibition may be given in the hormone-sensitive setting)
- Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer. A waiver may be obtained from the PI in cases where the active malignancy is indolent and believed not to reduce mortality.
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI).
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
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 |
|---|---|---|
| BiopsyA biopsy will be taken from metastatic tissue, which will be used for DNA sequencing | Procedure or surgery | Group 1: no sequencing, Group 2: no druggable aberration, Group 3: allocated to personalized treatment |
| Blood sampleBlood samples will be taken for additional translational research | Procedure or surgery | Group 1: no sequencing, Group 2: no druggable aberration, Group 3: allocated to personalized treatment |
Primary outcome
Responsiveness ratio
Time frame: Throughout completion of study (estimated 5 years from start)
Ratio of radiographic progression-free survival of personalized treatment or standard of care to the standard last line therapy (PFS-MPT-ratio vs PFS-SOC-ratio)
12 secondary outcomes
Efficacy endpoint: ORR
Time frame: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: rPFS
Time frame: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: PSA response
Time frame: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: PSA-PFS
Time frame: Throughout completion of study (estimated 5 years from start)
Efficacy endpoint: OS
Time frame: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EORTC-QLQ-30
Time frame: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EPIC-26
Time frame: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: EQ-5D-5L
Time frame: Throughout completion of study (estimated 5 years from start)
Quality of life endpoint: BIP-SF
Time frame: Throughout completion of study (estimated 5 years from start)
Medical Resource Utilization (MRU); nr of lines
Time frame: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Medical Resource Utilization (MRU); costs
Time frame: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Medical Resource Utilization (MRU); treatment-related costs
Time frame: At the end of year 1, year 2, year 3, and at completion of the study (estimated end of year 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- 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.
Iris Kloots, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer, run by Radboud University Medical Center 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 23 inclusion and 6 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 Feb 2021. 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?
Contact Niven Mehra, MD, PhD (+312410354, niven.mehra@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsiveness ratio (time frame: Throughout completion of study (estimated 5 years from 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 Feb 2021.