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NCT04978675
An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer
Phase 1 trial testing Fluorine F 18 rhPSMA-7.3 in Biochemically Recurrent Prostate Carcinoma in 29 participants. Completed in 4 June 2024.
4 June 2024
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 29 |
| Start date | 4 August 2021 |
| Primary completion | 4 June 2024 |
| Estimated completion | 4 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fluorine F 18 rhPSMA-7.3 — full drug profile →
- Magnetic Resonance Imaging
- Positron Emission Tomography
Conditions studied
- Biochemically Recurrent Prostate Carcinoma — all drugs for Biochemically Recurrent Prostate Carcinoma →
- Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, male only, with Biochemically Recurrent Prostate Carcinoma or Localized Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate surgery (biochemically recurrent). An increase in PSA levels alone does not tell the doctor where the cancer may be or how much cancer there may be. Imaging tests, like a bone scan, MRI, and/or computed tomography, are often performed to help the doctor learn where or how much cancer there is, and how best to treat the cancer. rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific membrane antigen (PSMA) is a protein that is expressed in prostate cancer and this agent targets the PSMA molecule. Giving rh PSMA 7.3 during PET/MRI may help doctors better find where the cancer may be spreading and how much of it there is. The results of this trial may also guide in radiotherapy planning.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radiolabeled PSMA Inhibitors.
Neels OC, Kopka K, Liolios C, Afshar-Oromieh A. · · 2021 · cited 28× · PMID 34944875 · DOI 10.3390/cancers13246255 -
Management of Patients with Recurrent and Metachronous Oligometastatic Prostate Cancer in the Era of PSMA PET.
Sabbagh A, Mohamad O, Lichter KE, Hope TA. · · 2022 · cited 9× · PMID 36551678 · DOI 10.3390/cancers14246194
Verify or expand the search:
- PubMed search for NCT04978675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Biochemically Recurrent Prostate Carcinoma
Currently open trials in the same condition.
- NCT07073794 — Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recu · Phase 2 · recruiting
- NCT06813898 — An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial · EARLY_PHASE1 · recruiting
- NCT06378866 — Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivati · Phase 2 · recruiting
- NCT06205316 — SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma · Phase 3 · recruiting
- NCT06105918 — Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Bioch · Phase 1 · active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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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 NCT04978675 (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 M.D. Anderson Cancer Center
- Last refreshed: 23 October 2024
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/NCT04978675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing