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Tests treatment safety and results for PSMA PET-Positive Castration-Resistant Prostate Cancer
Official title Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)
ClinicalTrials.gov ID: NCT06549465
What this study is testing
What is In-111 rosopatamab tetraxetan?
In-111 rosopatamab tetraxetan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for psma pet-positive castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
- Serum PSA progression as defined by PCWG3 (rising PSA consisting of two consecutive increases measured at least 3 weeks apart, of a rise of \>25%...
- Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of...
- Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan
- Identification of new soft tissue or bone lesions on PSMA PET imaging
You likely can't join if
- Superscans by nuclear medicine/99mTc bone scan
- A known malignancy that is progressing or has required active treatment within the past 3 years other than CRPC, which is expected to alter life...
- Prior platinum-based chemotherapy
- Prior PARP inhibitors (e.g., olaparib or rucaparib)
- Prior treatment with Radium-223, Actinium-225, Strontium-89, Samarium-153, Rheunium-186, or Rhenium-188
- Participants receiving anti-coagulants or anti-platelet drugs (e.g., aspirin or nonsteroidal anti-inflammatory drugs [NSAIDs]) who cannot discontinue...
See the full eligibility criteria
- Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
- Serum PSA progression as defined by PCWG3 (rising PSA consisting of two consecutive increases measured at least 3 weeks apart, of a rise of \>25%, and with an absolute rise of 2.0 ng/mL.
- Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the...
- Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan
- Identification of new soft tissue or bone lesions on PSMA PET imaging
- Metastatic disease defined as either or both of the following:
- Parts 1, 2, 3, and 4: Documented M1 disease on conventional imaging (CT/MRI of the chest/abdomen/pelvis and/or Technetium 99m [99mTc] whole-body bone scan)
- Parts 1, 2, and 4 only: Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent
- PSMA PET-positive disease, defined as at least one PSMA-positive metastatic lesion and no PSMA-negative lesions
- Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate)
- The standard of care use (in the setting of metastatic CRPC with significant burden of active bone metastases) of antiresorptive bone-targeted agents (e.g., zoledronic acid, denosumab) is required for all participants...
- Participants with HIV are eligible if they are well-controlled (i.e, an undetectable HIV viral load (\<50 copies/mL) within 6 months of enrollment and a stable ART regimen for at least 6 months prior to enrollment) and...
- Prior treatment with Lu-177-PSMA-radioligand therapy
- Prior treatment with up to only one taxane-based chemotherapy regimen is allowed
- Superscans by nuclear medicine/99mTc bone scan
- A known malignancy that is progressing or has required active treatment within the past 3 years other than CRPC, which is expected to alter life expectancy or may interfere with CRPC disease assessment
- Prior platinum-based chemotherapy
- Prior PARP inhibitors (e.g., olaparib or rucaparib)
- Prior treatment with Radium-223, Actinium-225, Strontium-89, Samarium-153, Rheunium-186, or Rhenium-188
- Participants receiving anti-coagulants or anti-platelet drugs (e.g., aspirin or nonsteroidal anti-inflammatory drugs [NSAIDs]) who cannot discontinue use if platelet count decreases to \<50,000 Part 2 and 4 Only:
- Prior chemotherapy for CRPC. Prior taxane chemotherapy for HSPC is allowed if discontinued ≥1 year prior to randomization
- Prior radiopharmaceutical therapy (e.g., Ra-223, Lu-177-PSMA-617, or Lu-177-PSMA-I\&T)
- Prior PSMA-targeted therapy, except for bispecific or CAR-T therapies Part 3 Only:
- Prior PSMA-targeted therapy (e.g., antibody-drug conjugates or CAR-T therapy), except for Lu-177-PSMA-radioligand therapy and bispecific or CAR-T therapies
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; New York, New York, United States; Durham, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.