Prostate CancerPhase 2NCT05806853
PET/MR for Prostate Cancer Restaging: a Phase II Prospective Monocentric Study
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 overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2) 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2020to 5 Oct 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
- Patients with histological proven diagnosis of prostate cancer.
- Patients treated with radical therapy (RP o EBRT, with or without further adjuvant therapies), who present rising serum PSA values ≥ 0.2 ng/mL.
- Age ≥ 18 years-old.
- Willing to provide a signed informed consent.
Who cannot join
- Age < 18 years-old.
- Previous and/or concomitant androgen deprivation therapy will be excluded.
- Any additional medical condition that may significantly interfere with study compliance.
- Contraindications to MR study (i.e. Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Prospective Monocentric Study on Prostate Cancer Restaging by Using PET/MR With Innovative Radiotracers
The overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2)
Read the detailed description
Sixty consecutive patients with biochemical recurrence (PSA≥0.2 ng/ml), previously treated with radical prostatectomy for organ confined prostate cancer will be enrolled; patients with previous and/or concomitant androgen deprivation therapy will be excluded from enrolment.
All patients will undergo both 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging at San Raffaele Scientific Institute in two different days; all clinical and pathological variables available at the time of PET/MR studies will be recorded for each patient.
PET/MR results will be compared to other imaging procedures performed and available in the course of routinely work-up evaluation. Treatment approach will be based on all available clinical and instrumental data, including 68Ga-PSMA and 68Ga-RM2 PET/MR, evaluated during multidisciplinary sessions including expert Urologists, Nuclear Medicine and Radiologist physicians. Patients with local recurrence will be candidate to salvage radiation therapy (sRT). Patients presenting only LN recurrence will be proposed to be submitted to salvage lymph node (LN) dissection (sLND) or sRT; alternatively, conventional androgen deprivation therapy will be performed in those patients who will not be willing to undergo secondary surgery or radiation therapy.
To assess the diagnostic accuracy of 68Ga-PSMA and 68Ga-RM2 PET/MR, images will be validated with: 1) histology (when deemed necessary by the clinician as expected under the normal care pathway) obtained by echographically-guided biopsy in suspected local recurrence or during sLND in the event of suspected nodal recurrence; 2) biochemical response after tailored treatment in patients submitted to sRT for local or LN recurrence 3) conventional imaging modalities performed to assess disease status as part of the routine clinical work-up. 68Ga-PSMA and 68Ga-RM2 PET/MR will be correlated with available clinical and pathological features. To assess the impact of 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR in changing patients' management, patients will be followed-up after the execution of PET/MR studies. Patients will be followed-up until the end of the study period
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA, 68Ga-RM2
- Keywords
- prostate cancer, biochemical recurrence, PET/MR
- 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
Glu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)] (68Ga-PSMA)
68Ga-RM2Drug
Bombesin receptor antagonist (68Ga-RM2)
| Study group | Role | What they receive |
|---|---|---|
| Dual tracer PET/MRI | Experimental | All patients undergo PET/MRI with 68Ga-PSMA and 68Ga-DOTA-RM2. 68Ga-PSMA dose: 160 +-50 MBq, route of administration: intravenous 68Ga-DOTA-RM2 dose: 140 +-50 MBq, route of administration: intravenous 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 evaluate the diagnostic accuracy of 68Ga-PSMA PET/MR to identify the site of recurrence in patients with biochemical relapse of PCa after primary treatment and comparison with the performances of 68Ga-RM2 PET/MR
Diagnostic accuracy will be measured by sensitivity, specificity, positive predicted value and negative predicted value
Measured: Imaging will be performed at T0 and T1 (at least 2 days apart). PET/MR results will be compared to other imaging procedures performed in the course of routinely work-up evaluation.
Secondary outcomes (2)
To correlate 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging with clinical and pathological features.
Univariate and multivariate logistic regression will be used to study the association (measured with odds ratio) between clinical/histopathological data and imaging findings. The clinical/histoapthological data that will be considered are ISUP grade, age (years), time between radical treatment and biochemical recurrence (months), PSA at time of imaging (ng/ml), initial PSA (ng/ml), PSA doubling time and PSA velocity.
Measured: Imaging will be performed at T0 and T1 (at least 2 days apart). Analysis after enrollment completion
To evaluate the results of a lesion-targeted approach in terms of biochemical-recurrence-free survival and clinical recurrence-free survival
To assess the impact of 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR in changing patients' management, patients will be followed-up after the execution of PET/MR studies. Patients will be followed-up until the end of the study period.
Measured: 0-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start3 Jun 2020
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
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
- 60 participants (actual)
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
- NCT05806853
- Sponsor's protocol ID
- PCa Restaging- PET/MR
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Monocentric Study on Prostate Cancer Restaging by Using PET/MR With Innovative Radiotracers
- ClinicalTrials.gov ID
- NCT05806853
- Acronym / sponsor ID
- PCa Restaging- PET/MR
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, biochemical recurrence, PET/MR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 10 Apr 2023 (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 overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2)
Detailed description
Sixty consecutive patients with biochemical recurrence (PSA≥0.2 ng/ml), previously treated with radical prostatectomy for organ confined prostate cancer will be enrolled; patients with previous and/or concomitant androgen deprivation therapy will be excluded from enrolment.
All patients will undergo both 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging at San Raffaele Scientific Institute in two different days; all clinical and pathological variables available at the time of PET/MR studies will be recorded for each patient.
PET/MR results will be compared to other imaging procedures performed and available in the course of routinely work-up evaluation. Treatment approach will be based on all available clinical and instrumental data, including 68Ga-PSMA and 68Ga-RM2 PET/MR, evaluated during multidisciplinary sessions including expert Urologists, Nuclear Medicine and Radiologist physicians. Patients with local recurrence will be candidate to salvage radiation therapy (sRT). Patients presenting only LN recurrence will be proposed to be submitted to salvage lymph node (LN) dissection (sLND) or sRT; alternatively, conventional androgen deprivation therapy will be performed in those patients who will not be willing to undergo secondary surgery or radiation therapy.
To assess the diagnostic accuracy of 68Ga-PSMA and 68Ga-RM2 PET/MR, images will be validated with: 1) histology (when deemed necessary by the clinician as expected under the normal care pathway) obtained by echographically-guided biopsy in suspected local recurrence or during sLND in the event of suspected nodal recurrence; 2) biochemical response after tailored treatment in patients submitted to sRT for local or LN recurrence 3) conventional imaging modalities performed to assess disease status as part of the routine clinical work-up. 68Ga-PSMA and 68Ga-RM2 PET/MR will be correlated with available clinical and pathological features. To assess the impact of 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR in changing patients' management, patients will be followed-up after the execution of PET/MR studies. Patients will be followed-up until the end of the study period
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual tracer PET/MRI | Experimental | Drug: 68Ga-PSMA, Drug: 68Ga-RM2All patients undergo PET/MRI with 68Ga-PSMA and 68Ga-DOTA-RM2. 68Ga-PSMA dose: 160 +-50 MBq, route of administration: intravenous 68Ga-DOTA-RM2 dose: 140 +-50 MBq, route of administration: intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histological proven diagnosis of prostate cancer.
- Patients treated with radical therapy (RP o EBRT, with or without further adjuvant therapies), who present rising serum PSA values ≥ 0.2 ng/mL.
- Age ≥ 18 years-old.
- Willing to provide a signed informed consent.
Key exclusion criteria (4 listed)
- Age < 18 years-old.
- Previous and/or concomitant androgen deprivation therapy will be excluded.
- Any additional medical condition that may significantly interfere with study compliance.
- Contraindications to MR study (i.e. Pacemaker
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-PSMAGlu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)] (68Ga-PSMA) | Drug | Dual tracer PET/MRI |
| 68Ga-RM2Bombesin receptor antagonist (68Ga-RM2) | Drug | Dual tracer PET/MRI |
Primary outcome
To evaluate the diagnostic accuracy of 68Ga-PSMA PET/MR to identify the site of recurrence in patients with biochemical relapse of PCa after primary treatment and comparison with the performances of 68Ga-RM2 PET/MR
Time frame: Imaging will be performed at T0 and T1 (at least 2 days apart). PET/MR results will be compared to other imaging procedures performed in the course of routinely work-up evaluation.
Diagnostic accuracy will be measured by sensitivity, specificity, positive predicted value and negative predicted value
2 secondary outcomes
To correlate 68Ga-PSMA PET/MR and 68Ga-RM2 PET/MR imaging with clinical and pathological features.
Time frame: Imaging will be performed at T0 and T1 (at least 2 days apart). Analysis after enrollment completion
To evaluate the results of a lesion-targeted approach in terms of biochemical-recurrence-free survival and clinical recurrence-free survival
Time frame: 0-36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the diagnostic accuracy of 68Ga-PSMA PET/MR to identify the site of recurrence in patients with biochemical relapse of PCa after primary treatment and comparison with the performances of 68Ga-RM2 PET/MR (time frame: Imaging will be performed at T0 and T1 (at least 2 days apart). PET/MR results will be compared to other imaging procedures performed in the course of routinely work-up evaluation.). 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 10 Apr 2023.