Prostate CancerPhase 1/2NCT02483884
PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer
A Phase 1/2 study testing [68Ga]RM2 and PET/CT in people with Prostate Cancer, run by Lantheus Biosciences Ltd. at 2 sites in 2 countries.
Trial summary
The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a standard of truth. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [68Ga]RM2 and PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 1/2
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients with diagnosis of primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
- Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
- Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
- The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
- No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled.
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- NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
- Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
- No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
- No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
- Life expectancy of at least 3 months.
Who cannot join
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
- Known sensitivity to the study drug or components of the preparation.
- Patient is in custody by order of an authority or a court of law.
- Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
- Unwillingness or inability to comply with the protocol.
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- Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety.
- Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
- History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
- Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer Administration.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site
Turku PET Centre/Department of Oncology and Radiotherapy
Turku, 20521
About this study
Official title: An Open-label, Multi Center PET/CT Study for Investigation of Safety and Diagnostic Performance of the 68Ga Labeled PET Tracer [68Ga]RM2 in Patients With Primary Prostate Cancer
The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a standard of truth.
This is an open-label, multi center PET/CT (positron emission tomography/computed tomography) non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled. Three strata of patients for the first part will be enrolled based on their pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10 patients with intermediate and 10 patients with high pretreatment risk of recurrence.
Read the detailed description
For inclusion, the prostate cancer needs to be histologically confirmed and MRI and PET/CT with [18F]-choline (18F-choline is not mandatory) should be available for comparison. Diagnostic [68Ga]RM2 will be injected intravenously into the subjects, and PET/CT imaging performed. Images will be assessed visually and quantitatively. Subjects should be scheduled for subsequent prostatectomy within 4 weeks after PET scan.
Prostate cancer will be confirmed by histopathological step-section analysis following prostatectomy and used as Standard of Truth. Based on the results of the initial 30 patients, an expansion cohort of 50 patients for Part 2 will be enrolled to increase the safety and tolerability database and to further characterize the uptake of [68Ga]RM2 in specific subsets.
- Conditions
- Prostate Cancer
- Being tested
- [68Ga]RM2, PET/CT
- Keywords
- Bombesin, Gastrin-Releasing Peptide, Prostatic Neoplasms, Genital Diseases, Male, Genital Neoplasms, Male, Neoplasms, Neoplasms by Site, Urogenital Neoplasms, Gastrointestinal Agents, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Pharmacologic Actions, Physiological Effects of Drugs, Therapeutic Uses
- Medical subject headings
- Prostatic Neoplasms, Genital Diseases, Male, Genital Neoplasms, Male, Neoplasms, Neoplasms by Site, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]RM2Drug
Also called [68Ga] labeled Bombesin derivative, Gallium Ga68-labeled GRPR antagonist RM2
[68Ga]RM2 is a novel 68Ga labeled, radiopharmaceutical agent for PET imaging. It is administered intravenously as a single dose of 140 MBq (corresponding to ≤ 40 μg mass dose)
PET/CTProcedure or surgery
Patients received [68Ga]RM2 undergo PET/CT 60 min p.i. for at least 20 min
| Study group | Role | What they receive |
|---|---|---|
| Low risk for recurrence | Experimental | Diagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with low risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. Receives: Drug: [68Ga]RM2; Procedure: PET/CT |
| Intermediate risk for recurrence | Experimental | Diagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with intermediate risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. Receives: Drug: [68Ga]RM2; Procedure: PET/CT |
| High risk for recurrence | Experimental | Diagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with high risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. Receives: Drug: [68Ga]RM2; Procedure: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of [68Ga]RM2 PET to identify lesions in comparison to whole-mount histopathology (number of histologically verified cancer lesions identified)
Measured: 60-80 min post injection
Secondary outcomes (5)
Accumulation and tumor detection-rate
Evaluation of [68Ga]RM2 accumulation and tumor detection-rate in patients with low, intermediate and high likelihood of recurrence according to pre-treatment risk stratification (NCCN guidelines).
Measured: 60-80 min post injection
Accumulation of [68Ga]RM2 in BPH
Assessment of the accumulation of [68Ga]RM2 in benign prostate hyperplasia (BPH) areas using whole mount sections of the prostate as standard of truth (SOT)
Measured: 60-80 min post injection
Proportion of lesions detected by [68Ga]RM2 PET in comparison to MRI and [18F]-choline (whenever available)
Comparison of [68Ga]RM2 findings to MRI, and [18F]-choline whenever available ([18F]-choline not mandatory)
Measured: 60-80 min post injection
Quantitative determination (Standardized Uptake Value [SUV]) of [68Ga]RM2 uptake in cancer lesions, stratified according to risk groups
Quantitative comparison of [68Ga]RM2 uptake in patients with low, intermediate or high likelihood of recurrence
Measured: 60-80 min post injection
Evaluation of SUV threshold
Exploratory evaluation of a quantitative (SUV) threshold to distinguish low, intermediate and high risk patients based on comparison with post-surgery histopathology
Measured: 60-80 min post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Business decision
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.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Stephens, MD, PhD, Study director, Piramal Imaging GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483884
- Sponsor's protocol ID
- RM2-01-01-14
- Other IDs
- 2014-003027-21, 2014
- Status last verified
- Mar 2017
- First submitted
- 11 Jun 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi Center PET/CT Study for Investigation of Safety and Diagnostic Performance of the 68Ga Labeled PET Tracer [68Ga]RM2 in Patients With Primary Prostate Cancer
- ClinicalTrials.gov ID
- NCT02483884
- Acronym / sponsor ID
- RM2-01-01-14
- Conditions
- Prostate Cancer
- Keywords
- Bombesin, Gastrin-Releasing Peptide, Prostatic Neoplasms, Genital Diseases, Male, Genital Neoplasms, Male, Neoplasms, Neoplasms by Site, Urogenital Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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 aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a standard of truth.
This is an open-label, multi center PET/CT (positron emission tomography/computed tomography) non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled. Three strata of patients for the first part will be enrolled based on their pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10 patients with intermediate and 10 patients with high pretreatment risk of recurrence.
Detailed description
For inclusion, the prostate cancer needs to be histologically confirmed and MRI and PET/CT with [18F]-choline (18F-choline is not mandatory) should be available for comparison. Diagnostic [68Ga]RM2 will be injected intravenously into the subjects, and PET/CT imaging performed. Images will be assessed visually and quantitatively. Subjects should be scheduled for subsequent prostatectomy within 4 weeks after PET scan.
Prostate cancer will be confirmed by histopathological step-section analysis following prostatectomy and used as Standard of Truth. Based on the results of the initial 30 patients, an expansion cohort of 50 patients for Part 2 will be enrolled to increase the safety and tolerability database and to further characterize the uptake of [68Ga]RM2 in specific subsets.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk for recurrence | Experimental | Drug: [68Ga]RM2, Procedure: PET/CTDiagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with low risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. |
| Intermediate risk for recurrence | Experimental | Drug: [68Ga]RM2, Procedure: PET/CTDiagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with intermediate risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. |
| High risk for recurrence | Experimental | Drug: [68Ga]RM2, Procedure: PET/CTDiagnostic [68Ga]RM2 is administered to 10 primary prostate cancer patients with high risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent.
- Patients with diagnosis of primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
- Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
- Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
- The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
Key exclusion criteria (10 listed)
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
- Known sensitivity to the study drug or components of the preparation.
- Patient is in custody by order of an authority or a court of law.
- Patient is a relative of the investigator, student of the investigator or otherwise dependent.
- Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
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 |
|---|---|---|
| [68Ga]RM2Also: [68Ga] labeled Bombesin derivative, Gallium Ga68-labeled GRPR antagonist RM2[68Ga]RM2 is a novel 68Ga labeled, radiopharmaceutical agent for PET imaging. It is administered intravenously as a single dose of 140 MBq (corresponding to ≤ 40 μg mass dose) | Drug | High risk for recurrence, Intermediate risk for recurrence, Low risk for recurrence |
| PET/CTPatients received [68Ga]RM2 undergo PET/CT 60 min p.i. for at least 20 min | Procedure or surgery | High risk for recurrence, Intermediate risk for recurrence, Low risk for recurrence |
Primary outcome
Sensitivity and specificity of [68Ga]RM2 PET to identify lesions in comparison to whole-mount histopathology (number of histologically verified cancer lesions identified)
Time frame: 60-80 min post injection
5 secondary outcomes
Accumulation and tumor detection-rate
Time frame: 60-80 min post injection
Accumulation of [68Ga]RM2 in BPH
Time frame: 60-80 min post injection
Proportion of lesions detected by [68Ga]RM2 PET in comparison to MRI and [18F]-choline (whenever available)
Time frame: 60-80 min post injection
Quantitative determination (Standardized Uptake Value [SUV]) of [68Ga]RM2 uptake in cancer lesions, stratified according to risk groups
Time frame: 60-80 min post injection
Evaluation of SUV threshold
Time frame: 60-80 min post injection
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
Andrew Stephens, MD, PhD study director
Piramal Imaging GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [68Ga]RM2 and PET/CT in people with Prostate Cancer, run by Lantheus Biosciences Ltd. at 2 sites in 2 countries.
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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 22 Mar 2017. 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 Austria, Finland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of [68Ga]RM2 PET to identify lesions in comparison to whole-mount histopathology (number of histologically verified cancer lesions identified) (time frame: 60-80 min post injection). 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 22 Mar 2017.