A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer


Condition: Biochemically Recurrent Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04216134

Sponsor: City of Hope Medical Center

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Biochemical recurrent prostate cancer
  • Karnofsky performance status of >= 50
  • The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
  • Co-enrollment on IRB 18517
  • Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients should not have any uncontrolled illness including ongoing or active infection
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
  • Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
  • Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

View trial on ClinicalTrials.gov