PSMA PET-Positive Castration-Resistant Prostate Cancer study: Single dose
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?
It is an investigational radio‑labeled antibody being studied as a potential treatment for PSMA PET‑positive castration‑resistant prostate cancer. It is designed to bind to PSMA on prostate cancer cells and deliver the radioactive isotope indium‑111 to those cells.
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 study aims to find the safest and most effective dose of a new radioactive antibody treatment for prostate cancer.
- Who it's for
- The study is looking for men with castration-resistant prostate cancer that shows up on a specific PET scan.
- What's involved
- Participants will receive injections of a radioactive antibody and undergo blood tests, heart checks, and imaging scans to monitor how the body handles the treatment.
- Time commitment
- The study involves multiple visits over several months, including specific days for treatment and follow-up checks.
- 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
- 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
- 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...
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
- Prior chemotherapy for CRPC. Prior taxane chemotherapy for HSPC is allowed if discontinued ≥1 year prior to randomization
See the full eligibility 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
- 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...
- 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
- 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 (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 is enrolling
- San Diego, California, United States
- Boston, Massachusetts, 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, but 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?
This study is enrolling now at San Diego, California, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States; Durham, North Carolina, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.