Last reviewed · How we verify
NCT04796467
68Ga-P16-093 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
Phase 2, PHASE3 trial testing 68Ga-PSMA-617 in Prostate Cancer in 50 participants. Status unknown.
1 August 2021
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 1 October 2020 |
| Primary completion | 1 August 2021 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- 68Ga-PSMA-617 — full drug profile →
- 68Ga-P16-093 — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 90, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Head-to-head comparison of [<sup>68</sup> Ga]Ga-P16-093 and [<sup>68</sup> Ga]Ga-PSMA-617 in dynamic PET/CT evaluation of the same group of recurrent prostate cancer patients.
Wang G, Hong H, Zang J, Liu Q, et al · · 2022 · cited 17× · PMID 34557930 · DOI 10.1007/s00259-021-05539-1 -
Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.
Ng TSC, Gao X, Salari K, Zlatev DV, et al · · 2021 · cited 4× · PMID 34395293 · DOI 10.3389/fonc.2021.722277 -
Head-to-Head Comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-617 in Dynamic PET/CT Evaluation of the Same Group of Recurrent Prostate Cancer Patients
Wang G, Hong H, Zang J, Liu Q, et al · · 2021 · DOI 10.21203/rs.3.rs-739096/v1
Verify or expand the search:
- PubMed search for NCT04796467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 68Ga-PSMA-617
Trials testing the same drug.
- NCT05841992 — Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients · Phase 2, PHASE3 · unknown
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet 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 NCT04796467 (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 Peking Union Medical College Hospital
- Last refreshed: 9 August 2022
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/NCT04796467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing