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

NCT06655064 | Terminated

• 1 other identifier: 68Ga-PtableSMA-11-404
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PSMA; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate Cancer Long Term Outcomes

  Long term outcomes of patients with newly diagnosed or recurrent disease prostate cancer or those being evaluated for radioligand therapy, who undergo 68Ga-PSMA-11PET/CT imaging for clinical management.

  3 years

Secondary Outcomes (6)

• Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection

  1.5 years

• Patient Demographic and Clinical Characteristics

  1.5 years

• Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer

  1.5 years

• Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning

  1.5 years

• Differential Use across Racial and Ethnic Groups

  3 years

Study Arms (3)

Group 1: Newly Diagnosed

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.

Other: None- Observational

Group 2: Previously Treated

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).

Other: None- Observational

Group 3: RLT Candidates

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

Other: None- Observational

Interventions

None- Observational OTHER

None- Observational

Group 1: Newly Diagnosed; Group 2: Previously Treated; Group 3: RLT Candidates

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.

You may qualify if:

• Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
• 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).
• Have histopathologically confirmed prostate adenocarcinoma.
• Have a life expectancy of ≥ 6 months as determined by the investigator.
• 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.
• 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.
• Be willing and able to provide informed consent and comply with the protocol requirements.

You may not qualify if:

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

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead
• Specialty Networks Research.: collaborator

Study Sites (9)

Valley Urology

Fresno, California, 93710, United States

Location

Urology Associates of Central California

Fresno, California, 93720, United States

Location

Urological Associates of Western Colorado

Grand Junction, Colorado, 81505, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

Urology Nevada

Reno, Nevada, 89511, United States

Location

Oregon Urologic Institute

Springfield, Oregon, 97477, United States

Location

Jackson Urological Associates

Jackson, Tennessee, 38301, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Aimal Ahmed, MD

  Telix Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: January 30, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (9)