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NCT04825652
177Lu-PSMA-617 Managed Access Program for mCRPC Patients
trial testing 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer (mCRPC). No longer available.
Quick facts
| Lead sponsor | Advanced Accelerator Applications |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- 177Lu-PSMA-617 — full drug profile →
- PSMA-11 — full drug profile →
Conditions studied
- Metastatic Castration-resistant Prostate Cancer (mCRPC) — all drugs for Metastatic Castration-resistant Prostate Cancer (mCRPC) →
Sponsor
Advanced Accelerator Applications — full company profile →
Who can join
18 and older, male only, with Metastatic Castration-resistant Prostate Cancer (mCRPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and Toxicity of [<sup>177</sup>Lu]Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: Results from the U.S. Expanded-Access Program and Comparisons with Phase 3 VISION Data.
Murthy V, Voter AF, Nguyen K, Allen-Auerbach M, et al · · 2024 · cited 8× · PMID 39327018 · DOI 10.2967/jnumed.124.267816 -
PSMA PET/CT-Derived Indicators and Outcomes After [<sup>177</sup>Lu]Lu-PSMA-617: A Multicenter Retrospective Analysis from the U.S. Expanded-Access Program.
Kimura K, Murthy V, Voter AF, Solnes LB, et al · · 2026 · PMID 41679922 · DOI 10.2967/jnumed.125.270789 -
Linking Baseline PSMA PET-Derived Parameters to Toxicity, Adverse Events, Pain, and Quality of Life in Patients Treated with [<sup>177</sup>Lu]Lu-PSMA-617: A Single-Center Retrospective Study.
Murthy V, Kimura K, Theus L, Nguyen A, et al · · 2026 · PMID 41344853 · DOI 10.2967/jnumed.125.270916
Verify or expand the search:
- PubMed search for NCT04825652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 177Lu-PSMA-617
Trials testing the same drug.
- NCT07145177 — 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer · Phase 1 · recruiting
- NCT06783348 — Radiopharmaceutical Treatment of Advanced Kidney Cancer · Phase 2 · not yet recruiting
- NCT07025512 — 177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia · Phase 2 · suspended
- NCT06964958 — 177LuPSMA in Renal Cell Carcinoma · Phase 2 · active not recruiting
- NCT06461689 — Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant · completed
Other recruiting trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Currently open trials in the same condition.
- NCT06136650 — A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resist · Phase 3 · recruiting
- NCT05107674 — A Study of NX-1607 in Adults With Advanced Malignancies · Phase 1 · recruiting
Other Advanced Accelerator Applications trials
Trials by the same sponsor.
- NCT04711135 — Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Phase 2 · active not recruiting
- NCT04524442 — Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patie · Phase 4 · completed
- NCT03972488 — Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET · Phase 3 · active not recruiting
- NCT03872778 — [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake · Phase 1, PHASE2 · completed
- NCT03691064 — Post-Authorization Long-Term Safety Study of LUTATHERA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04825652 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advanced Accelerator Applications
- Last refreshed: 13 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04825652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing