Prostate CancerPhase 2CROSSBOWNCT04085991
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
A Phase 2 study testing 131I-PSMA-1095 Radioligand Therapy (RLT) in people with Prostate Cancer and Prostate Adenocarcinoma, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms
- What is being tested?
- 131I-PSMA-1095 Radioligand Therapy (RLT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2020to 15 Jan 2023
- 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
- Male
- Age 18 years or older
- Documented metastatic adenocarcinoma of the prostate
- Under active medical oncology care
- ECOG performance status 0 - 3, inclusive
- Able to understand and provide written informed consent
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- Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes
- Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator
- Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1
- Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX
- Life expectancy of at least 3 months as judged by the investigator
Who cannot join
- Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
- Unmanageable claustrophobia
- Prior failure of PSMA RLT
- Prior hemi-body irradiation
- Impaired organ function as evidenced by any of the following laboratory values:
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- Absolute neutrophil count < 1.5 x109/L
- Platelet count < 75 x109/L
- Hemoglobin < 85 g/L
- Albumin < 2.5 g/dL (25 g/L)
- Total bilirubin > 2 x ULN (unless in instances of Gilbert's disease)
- AST or ALT > 2.5 x ULN (or > 5.0 x ULN in the presence of liver metastases)
Trial locations and contacts
1 site in 1 country.
About this study
Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms, Metastatic Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Metastatic Prostate Carcinoma in the Soft Tissue
- Being tested
- 131I-PSMA-1095 Radioligand Therapy (RLT)
- Keywords
- Radioligand therapy, PSMA, PSMA therapy, 1095
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-PSMA-1095 Radioligand Therapy (RLT)Drug
Also called PSMA RLT
Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| 131I-PSMA-1095 Radioligand Therapy (RLT) | Experimental | Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses Receives: Drug: 131I-PSMA-1095 Radioligand Therapy (RLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum prostate specific antigen (PSA)
The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.
Measured: 3 months post last dose of RLT
Secondary outcomes (1)
Adverse events
Frequency of adverse events in participants receiving therapy as per CTCAE v5.0
Measured: 3 months post last dose of RLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start31 Jul 2020
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Why it stopped: Drug no longer available
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Probst, MD, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Stephan Probst, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085991
- Sponsor's protocol ID
- CROSSBOW
- Acronym
- CROSSBOW
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT04085991
- Acronym / sponsor ID
- CROSSBOW / CROSSBOW
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms, Metastatic Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Metastatic Prostate Carcinoma in the Soft Tissue
- Keywords
- Radioligand therapy, PSMA, PSMA therapy, 1095
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug no longer available
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 11 Sep 2019 (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.
Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 131I-PSMA-1095 Radioligand Therapy (RLT) | Experimental | Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male
- Age 18 years or older
- Documented metastatic adenocarcinoma of the prostate
- Under active medical oncology care
- ECOG performance status 0 - 3, inclusive
Key exclusion criteria (12 listed)
- Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
- Unmanageable claustrophobia
- Prior failure of PSMA RLT
- Prior hemi-body irradiation
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 |
|---|---|---|
| 131I-PSMA-1095 Radioligand Therapy (RLT)Also: PSMA RLTIntravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses. | Drug | 131I-PSMA-1095 Radioligand Therapy (RLT) |
Primary outcome
Serum prostate specific antigen (PSA)
Time frame: 3 months post last dose of RLT
The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.
1 secondary outcome
Adverse events
Time frame: 3 months post last dose of RLT
Results and safety
The study was stopped early (reason given: Drug no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
Stephan Probst, MD principal investigator
Jewish General Hospital
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 131I-PSMA-1095 Radioligand Therapy (RLT) in people with Prostate Cancer and Prostate Adenocarcinoma, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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 11 inclusion and 12 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 12 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 Canada. 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 was stopped early (reason given: Drug no longer available). 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?
Serum prostate specific antigen (PSA) (time frame: 3 months post last dose of RLT). 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 12 Apr 2023.