Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations

Telix Pharmaceuticals

Status: Terminated

Conditions: Prostate Cancer (Adenocarcinoma)

Treatments: Other: None- Observational

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT06655064

68Ga-PtableSMA-11-404

Details and patient eligibility

About

The purpose of this observational research registry is to understand the real-world use of Illuccix PET/CT in prostate cancer, and how results from this testing impact patient's treatment and prostate cancer journey over time. It will follow subjects and the diagnostic testing and therapy they receive for their prostate cancer.

Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.

Enrollment: 120 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.

1. Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
2. Have undergone a 68Ga-PSMA-11 (Illuccix or Gozellix) PET/CT imaging evaluation within 60 days before enrolling in the study. (Prior imaging with alternate radioactive imaging agents are allowed, but enrollment imaging must be with 68Ga-PSMA-11(Illuccix or Gozellix).
3. Have histopathologically confirmed prostate adenocarcinoma.
4. Have a life expectancy of ≥ 6 months as determined by the investigator.
5. Participants intended for enrollment in Cohort 1: Patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation to evaluate potential spread of the disease.
6. Participants intended for enrollment in Cohort 2: Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11 PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels). Participants intended for enrollment in Cohort 3: Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.
7. Be willing and able to provide informed consent and comply with the protocol requirements.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply. All participants must NOT:

1. Have any medical condition or other circumstances that, in the opinion of the Investigator, compromises the safety of the participant, the ability of the participant to comply with protocol requirements, the ability of the participant to complete the study, or confound study outcomes by being unable to produce reliable data over the course of the study.

Trial design

120 participants in 3 patient groups

Group 1: Newly Diagnosed

Description:

Patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation to evaluate potential spread of the disease.

Treatment:

Other: None- Observational

Group 2: Previously Treated

Description:

Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels).

Treatment:

Other: None- Observational

Group 3: RLT Candidates

Description:

Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.

Treatment:

Other: None- Observational