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Pasritamig vs Placebo in late line Metastatic Castration-resistant Prostate Cancer (mCRPC)
EU CTIS ID: 2025-520927-26-00
What this study is testing
To determine if pasritamig + BSC compared to placebo + BSC is superior in OS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed NE carcinoma, large cell NE carcinoma, or sarcoma of the prostate is disallowed.
- 10. Hematologic Values Participants should have: - ANC ≥1.0 x 109/L. - Hemoglobin ≥8.0 g/dL. - Platelet count ≥75 x 109/L Note, transfusion or growth factor usage within 28 days of randomization is not allowed.
- 2. mCRPC: Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and 99mTc bone scan. Local-regional disease (eg.rectum, bladder, pelvis) can be included as long as participant has a current or past history of distant metastasis (M1 disease).
- 3. PSA ≥2 ng/mL at screening.
- 4. In the opinion of the investigator, the next best treatment option is a clinical trial.
- 5. Prior Therapy Requirements Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: ARPI: Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI. Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: a) Cabazitaxel is not available. b) The participant’s physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Participants who cannot continue taxane therapy because of a documented Grade ≥3 taxane-related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment. Radioligand therapy: Should have been previously treated with at least 1 dose of PSMA-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: a) PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b) The participant’s physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. PARPi: Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.
You likely can't join if
- 1. Venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤2) deep vein thrombosis is not exclusionary.
- 2. Active autoimmune disease within the 12 months prior to signing consent that quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).
- 3. Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 L/min by nasal cannula) to maintain adequate oxygenation.
- 4. Participant has a prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- 5. Any of the following within 6 months prior to first dose of study treatment: - Myocardial infarction - Severe or unstable angina - Clinically significant ventricular arrhythmias - Congestive heart failure (New York Heart Association class II to IV) - Transient ischemic attack - Cerebrovascular accident
- 6. Prior treatment with any CD3-directed therapy.
See the full eligibility criteria
Who can join
- 1. Histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed NE carcinoma, large cell NE carcinoma, or sarcoma of the prostate is disallowed.
- 10. Hematologic Values Participants should have: - ANC ≥1.0 x 109/L. - Hemoglobin ≥8.0 g/dL. - Platelet count ≥75 x 109/L Note, transfusion or growth factor usage within 28 days of randomization is not allowed.
- 2. mCRPC: Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and 99mTc bone scan. Local-regional disease (eg.rectum, bladder, pelvis) can be included as long as participant has a current or past history of distant metastasis (M1 disease).
- 3. PSA ≥2 ng/mL at screening.
- 4. In the opinion of the investigator, the next best treatment option is a clinical trial.
- 5. Prior Therapy Requirements Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: ARPI: Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI. Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: a) Cabazitaxel is not available. b) The participant’s physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Participants who cannot continue taxane therapy because of a documented Grade ≥3 taxane-related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment. Radioligand therapy: Should have been previously treated with at least 1 dose of PSMA-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: a) PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b) The participant’s physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. PARPi: Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.
- 6. Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase.
- 7. Have an ECOG performance status of 0 to 2.
- 8. Renal Function . Have an eGFR ≥30 mL/min, calculated with the CKD-epi formula, using adjusted BSA (at https://www.kidney.org/professionals/gfr_calculator), before randomization. Participants with obstructive uropathy should have treatment prior to randomization (eg, foley catheter, nephrostomy tubes, etc).
- 9. Hepatic Function Participants are eligible if they have the following values: - ALT and AST ≤5 ×ULN. - Serum total bilirubin ≤3 x ULN
What rules you out
- 1. Venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤2) deep vein thrombosis is not exclusionary.
- 2. Active autoimmune disease within the 12 months prior to signing consent that quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).
- 3. Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 L/min by nasal cannula) to maintain adequate oxygenation.
- 4. Participant has a prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- 5. Any of the following within 6 months prior to first dose of study treatment: - Myocardial infarction - Severe or unstable angina - Clinically significant ventricular arrhythmias - Congestive heart failure (New York Heart Association class II to IV) - Transient ischemic attack - Cerebrovascular accident
- 6. Prior treatment with any CD3-directed therapy.
- 7. Received immunosuppressive doses of systemic medications, such as glucocorticoids (doses >10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast (ie, for participants with allergies to contrast). If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, ≥7 days must have elapsed since the last dose of corticosteroid.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Canada
- Taiwan
- Korea, Republic of
- China
- United Kingdom
- Australia
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Canada; Taiwan; Korea, Republic of; China; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.