An observational study in Prostatic Neoplasms, Castration-Resistant and Neoplasm Metastasis, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Novartis Pharmaceuticals · Observational
This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.
84 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 30 are open to participants now.
This study's planned enrollment of 1,085 is above the median of 432 across 16 observational studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult male patients with mCRPC in the US and Germany, who received [177Lu]Lu-PSMA-617.
Exclusion criteria:
Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617.
A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage.
A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage.
Real-World Overall Survival (rwOS)
rwOS, defined as the time from index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, until death due to any cause.
Time frame: Up to approximately 3 years
Median rwOS
Median rwOS, defined as the time from the index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.
Time frame: Up to approximately 3 years
Baseline Demographics
Time frame: Baseline
Proportion of Patients by Clinical Characteristic
Clinical characteristics (based on data availability): * Symptoms and signs of PC * Tumor characteristics * Prostate-specific membrane antigen (PSMA) positivity (PSMA positive, PSMA negative) * Previous therapies
Time frame: Baseline
Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Time frame: Baseline
Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status
The Karnofsky performance status scale is an assessment scale used to measure an individual's functional status and ability to perform daily activities. The Karnofsky performance scale uses an 11-point scale in 10-point increments ranging from 100 (normal functioning) to 0 (deceased).
Time frame: Baseline
Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis
Time frame: Baseline
Prostate Specific Antigen (PSA) Level
Time frame: Baseline
Testosterone Level
Time frame: Baseline
Lactate Dehydrogenase (LDH) Level
Time frame: Baseline
Alkaline Phosphatase (ALP) Level
Time frame: Baseline
Real-World Progression Free Survival (rwPFS)
rwPFS, defined as the time from the index date to the date of first documented progression, or next treatment initiation, or death from any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Median rwPFS
Median rwPFS, defined as the time from the index date to when half of the patients in the cohort have disease progression or death.
Time frame: Up to approximately 3 years
Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation
Time frame: Baseline
Number of Patients by Number of [177Lu]Lu-PSMA-617 Cycles Received
Time frame: Up to approximately 3 years
Time Interval Between Two Consecutive [177Lu]Lu-PSMA-617 Cycles
Time frame: Up to approximately 3 years
Proportion of Patients With a Dose Modification
Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.
Time frame: Up to approximately 3 years
Time-to-First Dose Modification
Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.
Time frame: Up to approximately 3 years
Proportion of Patients who Discontinue Treatment
Time frame: Up to approximately 3 years
Proportion of Patients who Switch Treatment
Proportion of patients who discontinue \[177Lu\]Lu-PSMA-617 treatment and initiate new drug(s).
Time frame: Up to approximately 3 years
Time-to-Treatment Discontinuation (TTD1L)
Time frame: Up to approximately 3 years
Time-to-Next Treatment (TTNT)
Time from initiation of \[177Lu\]Lu-PSMA-617 until the start date of the next treatment or death, whichever occurs first.
Time frame: Up to approximately 3 years
Proportion of Patients With Adverse Events
Time frame: Up to 42 days after the last dose of [177Lu]Lu-PSMA-617
Proportion of Patients With Safety Topics of Interest (STIs)
STIs: renal events, myelosuppression (cytopenias, bone marrow failure), dry mouth, second primary malignancies (other malignancies than the primary prostate cancer, including hematological and solid malignancies), dry eye.
Time frame: Up to approximately 3 years
Proportion of Prescriptions by Type of Specialty
Time frame: Baseline, up to approximately 3 years
Proportion of Prescriptions by Type of Practice Setting
Time frame: Baseline, up to approximately 3 years
Proportion of Patients by Type of Other Metastatic Prostate Cancer (mPC) Treatments Prior to [177Lu]Lu-PSMA-617 Treatment
Time frame: Baseline
Proportion of Patients by Type of Other mPC Treatments After [177Lu]Lu-PSMA-617 Treatment
Time frame: Up to approximately 3 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Prostatic Neoplasms, Castration-Resistant→
Novartis Pharmaceuticals