Prostate Cancer (Adenocarcinoma)NCT06655064
Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations
An observational study of Prostate Cancer (Adenocarcinoma), run by Telix Pharmaceuticals (Innovations) Pty Limited at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- None- Observational
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jan 2025to 17 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.
Who may be able to join
- Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.
- 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.
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Valley Urology
Fresno, California, 93710
Urology Associates of Central California
Fresno, California, 93720
Urological Associates of Western Colorado
Grand Junction, Colorado, 81505
Jackson Urological Associates
Jackson, Tennessee, 38301
Idaho Urologic Institute
Meridian, Idaho, 83642
Urology Nevada
Reno, Nevada, 89511
Comprehensive Urology
Royal Oak, Michigan, 48073
Urology San Antonio
San Antonio, Texas, 78229
Oregon Urologic Institute
Springfield, Oregon, 97477
About this study
Official title: Prospective Observational Multicenter Registry Study to Assess the Impact & Long-Term Outcomes of 68Ga-PSMA-11 PET/CT Imaging Evaluations for Patients With Prostate Cancer (Newly Diagnosed, Suspected Recurrence P or Are Candidates for Radioligand Therapy)
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)
- Being tested
- None- Observational
- Keywords
- PSMA, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None- ObservationalOther
None- Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Other: None- Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection
Utilization of 68Ga-PSMA-1 PET/CT imaging for early recurrence detection in patients with low PSA (< 0.2 ng/mL).
Measured: 1.5 years
Patient Demographic and Clinical Characteristics
Demographic and clinical characteristics at time of imaging for prostate cancer patients undergoing 68Ga-PSMA-11 PET/CT imaging.
Measured: 1.5 years
Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer
Utilization of 68Ga-PSMA-11 PET/CT imaging for initial staging in low risk to favorable intermediate risk [(Grade Group 1 and 2: Gleason score 6 and 7 (3+4)] prostate cancer patients.
Measured: 1.5 years
Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning
Clinical impact of 68Ga-PSMA-11PET/CT imaging on staging and treatment planning in prostate cancer patients considered for radioligand therapy.
Measured: 1.5 years
Differential Use across Racial and Ethnic Groups
Differential use of 68Ga-PSMA-11 PET/CT imaging across racial and ethnic groups.
Measured: 3 years
Conventional Imaging
Utilization of 68Ga-PSMA-11PET/CT imaging in initial evaluation vs repeat conventional imaging in treatment planning decisions for patients with new and recurrent prostate cancer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Jan 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Why it stopped: Sponsor request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Specialty Networks Research.
- Responsible party
- Sponsor
- Investigators
- Aimal Ahmed, MD, Study director, Telix Pharmaceuticals (Innovations) Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655064
- Sponsor's protocol ID
- 68Ga-PtableSMA-11-404
- Status last verified
- Jul 2025
- First submitted
- 22 Oct 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Multicenter Registry Study to Assess the Impact & Long-Term Outcomes of 68Ga-PSMA-11 PET/CT Imaging Evaluations for Patients With Prostate Cancer (Newly Diagnosed, Suspected Recurrence P or Are Candidates for Radioligand Therapy)
- ClinicalTrials.gov ID
- NCT06655064
- Acronym / sponsor ID
- 68Ga-PtableSMA-11-404
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- PSMA, Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor request
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Specialty Networks Research.
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Newly Diagnosed | – | Other: None- ObservationalPatients 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. |
| Group 2: Previously Treated | – | Other: None- ObservationalPatients 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). |
| Group 3: RLT Candidates | – | Other: None- ObservationalPatients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.
Key inclusion criteria (8 listed)
- Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None- ObservationalNone- Observational | Other | Group 1: Newly Diagnosed, Group 2: Previously Treated, Group 3: RLT Candidates |
Primary outcome
Prostate Cancer Long Term Outcomes
Time frame: 3 years
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.
6 secondary outcomes
Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection
Time frame: 1.5 years
Patient Demographic and Clinical Characteristics
Time frame: 1.5 years
Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer
Time frame: 1.5 years
Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning
Time frame: 1.5 years
Differential Use across Racial and Ethnic Groups
Time frame: 3 years
Conventional Imaging
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimal Ahmed, MD study director
Telix Pharmaceuticals (Innovations) Pty Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by Telix Pharmaceuticals (Innovations) Pty Limited at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Long Term Outcomes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.