Castration-resistant Prostate CancerRESPECTNCT06321679
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone
An observational study of Castration-resistant Prostate Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone. This is a monocentric, prospective observational study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Imaging evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The estimated rate of recruitment to the study 6-7 patients a month, thus it is expected that patient accrual will be completed within 7 months. Based on recent treatment patterns, the expected distribution of treatments is: * Hormonal treatments * Enzalutamide: 14 patients * Abiraterone: 8 patients * Chemotherapy * Docetaxel: 11 patients * Cabazitaxel: 5 patients * Radiopharmaceutical drug - Radium-223: 2 patients
Who may be able to join
- Histological diagnosis of castration-resistant prostate cancer,
- Single or multiple bone metastases,
- Life expectancy of over 6 months,
- No current active malignancy other than prostate cancer,
- Provision of written informed consent.
Who cannot join
- Absolute contraindication to WB-MRI, CT or BS,
- Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
- Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IEO Istituto Europeo di Oncologia
Milan, 20141
Giuseppe Petralia, giuseppe.petralia@ieo.it
About this study
Official title: Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study
This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.
This is a monocentric, prospective observational study.
Read the detailed description
This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.
The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.
All patients will undergo imaging assessments as follows:
- At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
- Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.
Additional patient assessments to be performed include:
- questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities.
- clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS.
The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI.
Neither treating clinicians nor patients will be blinded at any point.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Imaging evaluation
- Keywords
- castration-resistant prostate cancer, whole body magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging evaluationProcedure or surgery
each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint
| Study group | Role | What they receive |
|---|---|---|
| WB-MRI | Each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint Receives: Procedure: Imaging evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression in bone metastasis identify by WB-MRI
the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS
Measured: 192 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Petralia, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321679
- Sponsor's protocol ID
- IEO 1269
- Acronym
- RESPECT
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study
- ClinicalTrials.gov ID
- NCT06321679
- Acronym / sponsor ID
- RESPECT / IEO 1269
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- castration-resistant prostate cancer, whole body magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 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.
This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.
This is a monocentric, prospective observational study.
Detailed description
This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.
The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.
All patients will undergo imaging assessments as follows:
- At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
- Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.
Additional patient assessments to be performed include:
- questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities.
- clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS.
The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI.
Neither treating clinicians nor patients will be blinded at any point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WB-MRI | – | Procedure: Imaging evaluationEach patient will undergo imaging with CT, BS and WB-MRI at each study timepoint |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The estimated rate of recruitment to the study 6-7 patients a month, thus it is expected that patient accrual will be completed within 7 months. Based on recent treatment patterns, the expected distribution of treatments is: * Hormonal treatments * Enzalutamide: 14 patients * Abiraterone: 8 patients * Chemotherapy * Docetaxel: 11 patients * Cabazitaxel: 5 patients * Radiopharmaceutical drug - Radium-223: 2 patients
Key inclusion criteria (5 listed)
- Histological diagnosis of castration-resistant prostate cancer,
- Single or multiple bone metastases,
- Life expectancy of over 6 months,
- No current active malignancy other than prostate cancer,
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- Absolute contraindication to WB-MRI, CT or BS,
- Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
- Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.
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 |
|---|---|---|
| Imaging evaluationeach patient will undergo imaging with CT, BS and WB-MRI at each study timepoint | Procedure or surgery | WB-MRI |
Primary outcome
Time to disease progression in bone metastasis identify by WB-MRI
Time frame: 192 weeks
the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
Related trials for Castration-resistant Prostate Cancer
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
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
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.
Giuseppe Petralia principal investigator
European Institute of Oncology
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 Castration-resistant Prostate Cancer, run by European Institute of Oncology 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Mar 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Petralia, MD (+39 02 9437 2901, giuseppe.petralia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression in bone metastasis identify by WB-MRI (time frame: 192 weeks). 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 20 Mar 2024.