Prostate CancerPhase 2NCT06484361
PET/MRI to Stage Prostate Cancer Patients
A Phase 2 study testing 68Ga-PSMA and 68Ga-RM2 in people with Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist). 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?
- 68Ga-PSMA and 68Ga-RM2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2020to 30 Sep 2025
- 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
- Age ≥ 18 years-old
- Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy.
- Willing to provide a signed informed consent
Who cannot join
- Age < 18 years-old
- Inability to complete the needed imaging examinations (i.e. severe claustrophobia)
- Any additional medical condition that may significantly interfere with study compliance
- All the contraindications for MRI study (i.e. pacemaker)
- Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Maria Picchio, MD, +39 02 26436117, picchio.maria@hsr.it
About this study
Official title: Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PET/MRI
The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist).
50 patients with biopsy proven PCa will be studied by PET/MRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy.
Read the detailed description
This is a prospective monocentric open study (Phase II study). The study will include 50 consecutive PCa patients who will be recruited in the first 36 months of the study. All clinical and pathological variables available at the time of PET/MRI will be recorded for each patient and all patients will take a blood sample before the first PET/MRI study. All patients will undergo 68Ga-PSMA and 68Ga-RM2 PET/MRI studies at San Raffaele Hospital in two different days (> 48 hours between the two studies) and within one month from each other.
Then, patients will undergo surgical intervention (prostatectomy and pelvic/retroperitoneal lymphadenectomy) and the surgically removed prostate will be fixated and processed. Ex-vivo 3T-MRI study will be performed on the processed specimen (prostate gland) and afterwards, the prostate will be examined by a dedicated pathologist. Spatial coregistration of in vivo, ex-vivo and histopathological images will be performed so that the annotation (dominant tumor lesion) made by the pathologist will be translated onto in vivo PET/MR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA, 68Ga-RM2
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMADrug
all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
68Ga-RM2Drug
all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Dual tracer PET/MRI Receives: Drug: 68Ga-PSMA; Drug: 68Ga-RM2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer
All patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 and then imaging findings will be correlated to histopathological findings gathered after prostatectomy. Specifically, at the patient level, we will count the number of patients where the different imaging modalities identified at least one intraprostatic cancer lesion. At the lesion level, on the other hand, we will match the intraprostatic lesions identified at imaging with those detected at histopathological examination. Therefore, providing measures of sensitivity, specificity, PPV, NPV for each imaging modality investigated ( 68Ga-PSMA PET, 68Ga-RM2 PET and MRI) at the lesion level.
Measured: baseline
Secondary outcomes (5)
To optimize PET/MRI with 68Ga-PSMA and 68Ga-RM2 protocol by using novel imaging technique to stage PCa patients.
The image acquisition protocol will be adjusted to ensure high quality of the images and patient compliance (measured with the number of patients that will complete all study procedures)
Measured: baseline
To characterize the primary PCa phenotype in high-grade patients
The correlation between Gleason Score and clinical data will be investigated with univariate and multivariate general linear models. Specifically, standardized uptake value (SUV)max and SUVmean of 68Ga-PSMA and 68Ga-DOTA-RM2, apparent diffusion coefficient (ADC)min and ADCmean, cellular markers in the peripheral blood, as well as radiomic features extracted from PET and mpMR images will be investigated.
Measured: baseline
To evaluate the stability and reproducibility of imaging features in mp-MRI with test-retest procedure.
Mann-whitney test will be used to assess the difference in the radiomic features extracted two days apart from the same MRI sequences
Measured: baseline
To evaluate the diagnostic accuracy of PET/MRI with 68Ga-PSMA and 68Ga-RM2 to stage T, N and M parameters in PCa patients.
To assess PET/MRI diagnostic accuracy for PCa primary staging (N and M) with 68Ga-PSMA and 68Ga-RM2, PET/MRI whole body images will be evaluated by a Nuclear Medicine and Radiology expert physicians, being aware of the patients' medical history and results of other imaging modalities. Histological data will be used as gold standard for the evaluation of diagnostic accuracy when possible; conventional imaging/follow-up will be used for the confirmation of M parameter. In case of positive findings, a histologic confirmation will be obtained when technically feasible. In particular, pelvic and/or retroperitoneal lymph nodes dissection will be performed in all patients included in the study. A biopsy of the suspicious lesion would be considered when possible in patients with metastases located in other sites. The diagnostic accuracy for T, N and M parameters will be measured with sensitivity, specificity, PPV and NPV at the patient level.
Measured: 24 months after baseline
To evaluate patient management based on PET/MRI studies.
It will be assessed in how many cases the PET/MRI studies affected the well-being patients, measured with survival analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start9 Sep 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (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 IRCCS San RaffaeleThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Picchio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484361
- Sponsor's protocol ID
- PETMR-Staging-PCa1
- Status last verified
- Jun 2024
- First submitted
- 22 Mar 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PET/MRI
- ClinicalTrials.gov ID
- NCT06484361
- Acronym / sponsor ID
- PETMR-Staging-PCa1
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Jul 2024 (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 main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist).
50 patients with biopsy proven PCa will be studied by PET/MRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy.
Detailed description
This is a prospective monocentric open study (Phase II study). The study will include 50 consecutive PCa patients who will be recruited in the first 36 months of the study. All clinical and pathological variables available at the time of PET/MRI will be recorded for each patient and all patients will take a blood sample before the first PET/MRI study. All patients will undergo 68Ga-PSMA and 68Ga-RM2 PET/MRI studies at San Raffaele Hospital in two different days (> 48 hours between the two studies) and within one month from each other.
Then, patients will undergo surgical intervention (prostatectomy and pelvic/retroperitoneal lymphadenectomy) and the surgically removed prostate will be fixated and processed. Ex-vivo 3T-MRI study will be performed on the processed specimen (prostate gland) and afterwards, the prostate will be examined by a dedicated pathologist. Spatial coregistration of in vivo, ex-vivo and histopathological images will be performed so that the annotation (dominant tumor lesion) made by the pathologist will be translated onto in vivo PET/MR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 68Ga-PSMA, Drug: 68Ga-RM2Dual tracer PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years-old
- Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy.
- Willing to provide a signed informed consent
Key exclusion criteria (5 listed)
- Age < 18 years-old
- Inability to complete the needed imaging examinations (i.e. severe claustrophobia)
- Any additional medical condition that may significantly interfere with study compliance
- All the contraindications for MRI study (i.e. pacemaker)
- Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
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-PSMAall patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention | Drug | Arm 1 |
| 68Ga-RM2all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention | Drug | Arm 1 |
Primary outcome
To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer
Time frame: baseline
All patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 and then imaging findings will be correlated to histopathological findings gathered after prostatectomy. Specifically, at the patient level, we will count the number of patients where the different imaging modalities identified at least one intraprostatic cancer lesion. At the lesion level, on the other hand, we will match the intraprostatic lesions identified at imaging with those detected at histopathological examination. Therefore, providing measures of sensitivity, specificity, PPV, NPV for each imaging modality investigated ( 68Ga-PSMA PET, 68Ga-RM2 PET and MRI) at the lesion level.
5 secondary outcomes
To optimize PET/MRI with 68Ga-PSMA and 68Ga-RM2 protocol by using novel imaging technique to stage PCa patients.
Time frame: baseline
To characterize the primary PCa phenotype in high-grade patients
Time frame: baseline
To evaluate the stability and reproducibility of imaging features in mp-MRI with test-retest procedure.
Time frame: baseline
To evaluate the diagnostic accuracy of PET/MRI with 68Ga-PSMA and 68Ga-RM2 to stage T, N and M parameters in PCa patients.
Time frame: 24 months after baseline
To evaluate patient management based on PET/MRI studies.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing 68Ga-PSMA and 68Ga-RM2 in people with Prostate Cancer, run by IRCCS San Raffaele at 1 site 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 3 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 3 Jul 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 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.
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 Maria Picchio, MD (+39 02 26436117, picchio.maria@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer (time frame: baseline). 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 3 Jul 2024.