Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sinotau Pharmaceutical Group
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1\. Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:
1. Radical prostatectomy (RP);
2. RP with adjuvant radiotherapy (RT);
3. RP with adjuvant androgen deprivation therapy (ADT);
4\. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
1. After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
2. After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
3. After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
5\. If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.
6\. Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.
You may not be if
1. Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
2. Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).
3. Known allergy to the active ingredient or any excipient of XTR020.
4. Claustrophobia or inability to tolerate imaging examinations for any other reason.
5. Poor compliance or deemed unsuitable for participation in this study by the investigator.
6. Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.
