Metastatic Castration Resistant Prostate Cancer (mCRPC)WB-LuPSMANCT05208229
The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)
An observational study of Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
Trial summary
The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- WB-MRI
- How many people
- 2 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2021to 8 Mar 2022
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with mCRPC enrolled in the IRST185.03 Lu-PSMA study
Who may be able to join
- Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation.
Who cannot join
- no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
Meldola, Forlì-Cesena, 47014
European Institute of Oncology
Milan
About this study
Official title: The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lu-PSMA
The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA
Read the detailed description
Multicentric, observational, single arm, prospective, study.
All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows:
- Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed
- At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed
- In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed.
Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.
- Being tested
- WB-MRI
- Keywords
- WB-MRI (Whole Body- Magnetic Resonance Imaging), 177Lu-PSMA 617, metastatic Castration Resistant Prostate Cancer (mCRPC), Radio Metabolic Therapy (RMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-MRIDiagnostic test
Baseline CT scan (minimum thorax/abdomen/pelvis) and WB-MRI evaluations will be collected: as per clinical practice and Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, the assessments must not be performed more than 12 weeks prior to study entry and baseline WB-MRI should be performed within 2 weeks from CT scan; CT and WB-MRI will be done at the end of Lutetium 177 PSMA (177Lu-PSMA) therapy and during post-treatment follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol | Patients with mCRPC enrolled in the IRST 185.03 Lu-PSMA study, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation. Receives: Diagnostic Test: WB-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria.
Measured: up to 42 months
Secondary outcomes (2)
Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI
To assess reproducibility of MET-RADS-P assessment of WB-MRI in metastatic prostate disease. The reproducibility of MET-RADS-P assessment of WB-MRI in metastatic prostate disease will be assessed using the concordance of the Response Assessment Categories (RAC) scores (RACs) assigned by two independent observers.
Measured: up to 42 months
response with WB-MRI compared to other assessment
Quantitative metrics describing patterns of response that can be observed on WB-MRI, on CT, and possibly on Ga PSMA Positron Emission Tomography (PET)/CT.
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Feb 2021
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Why it stopped: The study was linked to another protocol that is over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Paganelli, MD, Study chair, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208229
- Sponsor's protocol ID
- IRST185.08
- Acronym
- WB-LuPSMA
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lu-PSMA
- ClinicalTrials.gov ID
- NCT05208229
- Acronym / sponsor ID
- WB-LuPSMA / IRST185.08
- Keywords
- WB-MRI (Whole Body- Magnetic Resonance Imaging), 177Lu-PSMA 617, metastatic Castration Resistant Prostate Cancer (mCRPC), Radio Metabolic Therapy (RMT)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was linked to another protocol that is over
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 26 Jan 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.
The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA
Detailed description
Multicentric, observational, single arm, prospective, study.
All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows:
- Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed
- At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed
- In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed.
Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol | – | Diagnostic Test: WB-MRIPatients with mCRPC enrolled in the IRST 185.03 Lu-PSMA study, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with mCRPC enrolled in the IRST185.03 Lu-PSMA study
Key inclusion criteria (1 listed)
- Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation.
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| WB-MRIBaseline CT scan (minimum thorax/abdomen/pelvis) and WB-MRI evaluations will be collected: as per clinical practice and Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, the assessments must not be performed more than 12 weeks prior to study entry and baseline WB-MRI should be performed within 2 weeks from CT scan; CT and WB-MRI will be done at the end of Lutetium 177 PSMA (177Lu-PSMA) therapy and during post-treatment follow-up | Diagnostic test | Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol |
Primary outcome
disease progression
Time frame: up to 42 months
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria.
2 secondary outcomes
Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI
Time frame: up to 42 months
response with WB-MRI compared to other assessment
Time frame: up to 42 months
Results and safety
The study was stopped early (reason given: The study was linked to another protocol that is over). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Related trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
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.
Giovanni Paganelli, MD study chair
IRST IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites 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 1 inclusion and 1 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 1 Apr 2025. 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 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.
Are results available for this study?
The study was stopped early (reason given: The study was linked to another protocol that is over). 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?
disease progression (time frame: up to 42 months). 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 1 Apr 2025.