NCT06754085 Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
| NCT ID | NCT06754085 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | HTA Co., Ltd. |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 131 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 131 participants in total. It began in 2024-12-19 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, 18F-Florastamin PET/CT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
Eligibility Criteria
Inclusion Criteria: 1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF). 2. Male ≥ 18 years of age. 3. Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy. 4. Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions: 1. At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or 2. Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir . 5. Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment; 6. ECOG score 0 or 2. 7. Subjects who meet the following conditions in hematology, renal function, and liver function: Platelet count\>50 \* 10\^9/L Urea/urea nitrogen and creatinine\<1.5 times upper limits of normal AST and ALT\<2.5 times upper limits of normal. 8. Expected survival time ≥ 6 months. 9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration. Exclusion Criteria: 1. Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF. 2. Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration. 3. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration. 4. If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration. 5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754085 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754085 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 131 participants.
Is NCT06754085 currently recruiting?
Yes, NCT06754085 is actively recruiting participants. Contact the research team at fanwei@sysucc.org.cn for enrollment information.
Where is the NCT06754085 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06754085 clinical trial?
NCT06754085 is sponsored by HTA Co., Ltd.. The trial plans to enroll 131 participants.
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