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)
A Phase 2, Open-label 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws, Heart tracing (ECG), Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a radiation-based drug called Ac-225 rosopatamab tetraxetan for prostate cancer that has spread and keeps growing despite very low testosterone levels. The cancer must show a target called PSMA on a PET scan. Researchers will study where the drug goes in the body, its safety, different doses, and how well it works.
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. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Part 4 will be an extended regimen in dose escalation and expansion. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants qualifying for Part 4 will initially receive two doses (dose administration on Day 1 and Day 15) at the dose level selected in Part 2, followed by a single third dose of Ac-225 rosopatamab tetraxetan administered approximately 12 weeks after completion of the Part 2 fractionated dosing regimen. The starting dose level for Part 4 will be 22 kBq/kg (or fixed activity equivalent). Dose limiting toxicities (DLTs) will be monitored following administration of the third dose in Part 4 to determine the recommended phase 2 dose (RP2D) of a third dose of Ac-225 rosopatamab tetraxetan. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Your prostate cancer is getting worse despite very low testosterone levels, based on blood tests or scans.
- Scans show that the cancer has spread. Part 3 requires spread shown on standard scans, not just a PSMA PET scan.
- A PSMA PET scan shows at least one spot of cancer that has PSMA, and no cancer spots without PSMA.
- Your cancer got worse after hormone-lowering treatment (ADT) and at least one drug that blocks male hormones, such as enzalutamide or abiraterone.
- If you have a large amount of active cancer in your bones, you must use bone-protecting medicine for at least 4 weeks before the study drug, unless it is unsafe for you.
- If you have HIV, it must be well controlled: a viral level below 50 copies/mL within 6 months, stable HIV treatment for at least 6 months, and low risk of HIV-related illness.
- Part 3: You must have had Lu-177-PSMA treatment, which delivers radiation to cancer cells with PSMA.
- Part 3: You may have had no more than one treatment course using taxane chemotherapy.
Who can't join
- A bone scan shows a “superscan,” a pattern of unusually high activity across the bones.
- You have another cancer that is growing or needed treatment in the past 3 years and could affect your lifespan or the study's cancer checks.
- You have had platinum chemotherapy or a PARP inhibitor, such as olaparib or rucaparib.
- You have had radiation treatment with radium-223, actinium-225, strontium-89, samarium-153, rhenium-186, or rhenium-188.
- You take blood-thinning or anti-platelet drugs, such as aspirin, and cannot stop them if your platelet count falls below 50,000. Platelets help blood clot.
- Parts 2 and 4: You have had chemotherapy for prostate cancer that resists hormone-lowering treatment. Earlier taxane chemotherapy for hormone-sensitive cancer is allowed if it ended at least 1 year before study group assignment.
- Parts 2 and 4: You have had a radioactive drug treatment or a PSMA-targeted treatment. Bispecific antibody and CAR-T immune treatments are exceptions to the PSMA treatment rule.
- Part 3: You have had PSMA-targeted treatment other than Lu-177-PSMA radiation treatment, bispecific antibody treatment, or CAR-T immune treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: 1. 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. 2. 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 previous treatment was started or the appearance of one or more new lesions by CT/magnetic resonance imaging (MRI) 3. Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan 4. Identification of new soft tissue or bone lesions on PSMA PET imaging * Metastatic disease defined as either or both of the following: 1. 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) 2. 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 without a contraindication, for at least 4 weeks prior to administration of Ac-225 rosopatamab tetraxetan. * 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 at low risk for HIV-related illness Part 3 Only: * Prior treatment with Lu-177-PSMA-radioligand therapy * Prior treatment with up to only one taxane-based chemotherapy regimen is allowed Exclusion Criteria: * 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
Study sites (9)
CA
- University of California San Diego · San Diego, CA 92093Rana McKay, MD · Principal investigatorMore trials in San Diego
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Praful Ravi, MB, BChir, MRCP · Principal investigatorMore trials in Boston
MO
- Washington University in St. Louis · St Louis, MO 63130More trials in St Louis
NC
- Duke University Medical Center · Durham, NC 27710Daniel George, MD · Principal investigatorMore trials in Durham
NE
- X Cancer Omaha / Urology Cancer Center · Omaha, NE 68130-5606Luke Nordquist, MD · Principal investigatorMore trials in Omaha
NY
- Laura & Isaac Perlmutter Cancer Center · New York, NY 10016David Wise, MD · Principal investigatorMore trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Anis Hamid, MD · Principal investigatorMore trials in New York
- New York Presbyterian/Weill Cornell Medical Center · New York, NY 10065Cora Sternberg, MD · Principal investigatorMore trials in New York
OH
- The Cleveland Clinic Foundation · Cleveland, OH 44195Shilpa Gupta, MD · Principal investigatorMore trials in Cleveland