Evaluating a new treatment for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a three-part evaluation of the safety and efficacy of a PSMA-directed radioantibody, rospatamab tetraxetan, in patients with PSMA PET-positive castration-resistant prostate cancer (CRPC). The first part involves administering In-111-rosopatamab tetraxetan to assess its biodistribution in the body. Depending on their treatment history, participants will then be randomized into either a dose optimization phase or a dose escalation phase, where they will receive varying doses of Ac-225 rosopatamab tetraxetan. The study aims to monitor dose-limiting toxicities to establish the recommended phase 2 dose for further evaluation.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Diego
  San Diego, California, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• X Cancer Omaha / Urology Cancer Center
  Omaha, Nebraska, United States Recruiting
• Laura & Isaac Perlmutter Cancer Center
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• New York Presbyterian/Weill Cornell Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: CONVERGE01@convergentrx.com
• Phone: CONVERGE01

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observational study on Lutetium-177 treatment for metastatic prostate cancer

  This study is testing if Lutetium-177 treatment can help men with advanced prostate cancer feel better and understand how their bodies respond to the therapy.

  Recruiting Kuopio University Hospital · Kuopio, Northern Savonia · NCT06850545

• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

  This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07641049

• HRS-4357 versus novel androgen receptor pathway inhibitors for PSMA-positive metastatic castration-resistant prostate cancer

  This trial will test whether HRS-4357 works better than newer androgen receptor pathway drugs (like enzalutamide or abiraterone) for men with PSMA-positive metastatic castration-resistant prostate cancer.

  Recruiting Phase 3 Jiangsu HengRui Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07311694

• 177Lu-PSMA-VG01 Injection in PSMA-Positive Metastatic Prostate Cancer

  This phase 1 study tests whether intravenous 177Lu-PSMA-VG01 is safe and tolerable in men with PSMA-positive metastatic castration-resistant prostate cancer and looks at how the drug distributes in the body and early anti-tumor signals.

  Recruiting Phase 1 VitsGen Therapeutics Inc. · Shanghai, Shanghai Municipality · NCT07660211

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.