An observational study in Metastatic Castration-Resistant Prostate Cancer, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
This study aims to assess real-world clinical outcomes among adult metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with and progressed on an androgen receptor pathway inhibitor (ARPI) who received 177Lu-PSMA-617 as a monotherapy or with concurrent ARPI. The study will use secondary data taken from a United States oncology database.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 2,045 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult male patients with mCRPC treated with 177Lu-PSMA-617 with or without concurrent ARPI on/after March 23, 2022 who received prior and progressed on an ARPI therapy in the metastatic setting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of ARPI progression on the ARPI (LOT) immediately preceding 177Lu-PSMA-617 initiation, defined as
Exclusion criteria:
Applied to ARPI-experienced mCRPC patient cohort:
Individuals will be excluded if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
mCRPC patients receiving 177Lu-PSMA-617 without concurrent ARPI. ADT and/or 1st-generation antiandrogens are allowed in the line. No other therapies are permitted during the line.
mCRPC patients receiving 177Lu-PSMA-617 with concurrent ARPI. ADT and/or 1st-generation antiandrogens are allowed in the line. No other therapies are permitted in the line.
Real-world Overall Survival (rwOS)
rwOS defined as the time from the index date (177Lu-PSMA-617 treatment initiation) to date of death.
Time frame: Up to approximately 4 years
Real-world Time to Treatment Discontinuation (rwTTD)
rwTTD defined as the time from 177Lu-PSMA-617 index therapy start to 177Lu-PSMA-617 index therapy end (discontinuation, death, or ≥120-day gap).
Time frame: Up to approximately 4 years
Real-world Progression-free Survival (rwPFS)
rwPFS defined as the time from the start date of 177Lu-PSMA-617 to the date of first progression occurring more than 14 days after the LOT start date, or date of death if no progression event is observed.
Time frame: Up to approximately 4 years
Baseline Demographics
Time frame: Baseline
Number of Patients by Clinical Characteristics
Clinical characteristics such as Eastern Cooperative Oncology Group (ECOG) performance status category (0-1, 2+), prostate specific antigen (PSA) level, Gleason score category (\<8, ≥8), laboratory values, and prior ARPI LOTs.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2026, 0 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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