Prostate-specific Membrane AntigenBASKET PSMANCT03453528
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
A study testing 68Ga-PSMA in people with Prostate-specific Membrane Antigen and mCRPC or Advanced/Metastatic Solid Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate-specific Membrane Antigen, mCRPC or Advanced/Metastatic Solid Tumors
- What is being tested?
- 68Ga-PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,225 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jul 2017to 3 Jan 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mCRPC or advanced/metastatic solid tumors;
- Male or Female, aged >18 years;
- Written informed consent;
- Relapse or progression of disease on CT scan and / or MRI;
- If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Who cannot join
- Pregnancy / Nursing;
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry
- Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
- inability to remain still for the entire duration of the exam
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014
About this study
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
Read the detailed description
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.
- Being tested
- 68Ga-PSMA
- Keywords
- mCRPC or advanced/metastatic solid tumors, Prostate-specific membrane antigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMADrug
68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA | Experimental | 68Ga-PSMA Receives: Drug: 68Ga-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of 68Ga-PSMA PET/CT
the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors).
Measured: up to 36 months
Secondary outcomes (4)
Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
Measured: up to 36 months
Lesion detection rate stratified per tumor histotypes
Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes;
Measured: up to 36 months
Lesion detection rate stratified for different lesion sites
Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites;
Measured: up to 36 months
Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;
Changes in 68Ga-PSMA uptake in patients and correlation with clinical response to 177Lu-PSMA therapy for prostate cancer, or other angiogenic therapy.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start4 Jul 2017
- Primary completion4 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate-specific Membrane AntigenStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,225 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
- Paola Caroli, MD, Study chair, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453528
- Sponsor's protocol ID
- IRST100.34
- Acronym
- BASKET PSMA
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2018
- Last updated
- 8 Jan 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
- ClinicalTrials.gov ID
- NCT03453528
- Acronym / sponsor ID
- BASKET PSMA / IRST100.34
- Keywords
- mCRPC or advanced/metastatic solid tumors, Prostate-specific membrane antigen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 5 Mar 2018 (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.
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
Detailed description
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA | Experimental | Drug: 68Ga-PSMA68Ga-PSMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with mCRPC or advanced/metastatic solid tumors;
- Male or Female, aged >18 years;
- Written informed consent;
- Relapse or progression of disease on CT scan and / or MRI;
- If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.
Key exclusion criteria (5 listed)
- Pregnancy / Nursing;
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry
- Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
- inability to remain still for the entire duration of the exam
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-PSMA68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg). | Drug | 68Ga-PSMA |
Primary outcome
detection rate of 68Ga-PSMA PET/CT
Time frame: up to 36 months
the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors).
4 secondary outcomes
Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
Time frame: up to 36 months
Lesion detection rate stratified per tumor histotypes
Time frame: up to 36 months
Lesion detection rate stratified for different lesion sites
Time frame: up to 36 months
Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;
Time frame: up to 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 8 Jan 2025.
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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.
Paola Caroli, MD study chair
IRST IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-PSMA in people with Prostate-specific Membrane Antigen and mCRPC or Advanced/Metastatic Solid Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS 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 6 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: finished, as of the sponsor's last update on 8 Jan 2025. 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?
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?
detection rate of 68Ga-PSMA PET/CT (time frame: up to 36 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 8 Jan 2025.