Trial NCT06780670
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
- Phase
- Phase 2/3
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- Prostate Cancer
- Ages
- 18–100 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria: ∙
* adults ≥ 18 years of age.
* ECOG performance status of 0 to 2.Performance status
* histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
* PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
* castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
* Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
* ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
* eGFR as requested by the sponsor
Exclusion Criteria:
* Any investigational agents within 28 days prior to the day of randomization.
* Any 225Ac-based investigational compound used prior to the day of randomization.
* Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
* Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)Renal
* Baseline xerostomia ≥ Grade 2 by CTCAE v.5
* History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac diseaseCardiac
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).Prior malignancy
Other protocol-defined inclusion/exclusion criteria may apply.
Restrictions found (4)
- CardiacConditionalexclusion
within 6 months
Show in the text - Performance statusOutrightinclusion
ECOG 0 to 2
Show in the text - Prior malignancyConditionalexclusion
within 2 years
Show in the text - RenalConditionalexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County