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Prostate CancerNCT04769817

ProsTIC Registry of Men Treated With PSMA Theranostics

An observational study of Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
177Lu-PSMA
How many people
500 participants
Where
1 siteAustralia
Study dates
19 May 2021to 31 Dec 2028
How long will I take part?
4 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Men with mCRPC who have progressed after novel anti-androgen therapy and taxane chemotherapy (unless unfit and symptomatic).

Who may be able to join

  • Diagnosis of mCRPC
  • Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
  • Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
  • Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

About this study

Official title: Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.

Read the detailed description

The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.

Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.

The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.

Being tested
177Lu-PSMA
Keywords
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Theranostic, 177Lu-PSMA, Radionuclide Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMAOther

    Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA-RR

    Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.

    Measured: From baseline through to progression or death until registry completion (approx. 5 years).

Secondary outcomes (6)

  1. Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Safety of the combination will be measured by selected AEs and SAEs; only grade 3 or greater AEs related to 177Lu-PSMA with the exception of lymphopenia and fatigue or any grade 1-2 AEs that have not previously been reported with 177Lu-PSMA

    Measured: From date of treatment to 12 weeks after completing study treatment.

  2. Radiographic progression-free survival (rPFS)

    rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per response evaluation criteria in solid tumors (RECIST1.1) for soft tissue and prostate cancer working group three (PCWG3) for bone lesions.

    Measured: From date of treatment through to progression or death until registry completion (approx. 5 years).

  3. PSA progression free survival (PSA-PFS)

    PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later.

    Measured: From date of treatment through to progression or death until registry completion (approx. 5 years).

  4. Overall survival (OS)

    OS is defined as the time from treatment initiation to the date of death due to any cause.

    Measured: From date of treatment, up until 18 months after the last patient commences treatment.

  5. EORTC QLQ-C30

    The European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and quality-of-life scale. The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), as well as the perceived financial impact of the disease and treatment.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Measured: From baseline through to progression or death until registry completion (approx. 5 years).

  6. PPI

    Pain is measured using the McGill-Melzack Present Pain Intensity scale (PPI) Pain Response is defined for patients with a baseline PPI score of ≥2 or a baseline analgesic score of ≥10 points, as: (i) a PPI score reduction of ≥2 points from baseline with no increase in analgesic score; and/or, (ii) a decrease of ≥ 50 percent in analgesic score with no increase PPI.

    Measured: From baseline through to progression or death until registry completion (approx. 5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start19 May 2021
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
500 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04769817
Sponsor's protocol ID
PMC 20/164
Status last verified
May 2026
First submitted
6 Sep 2020
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen DC, Buteau JP, Papa N, Akhurst T, Alipour R, Bollampally N, Cardin A, Eifer M, Casanueva Eliceiry S, Jackson P, Jewell K, Kashyap R, Kong G, Kostos L, Ravi Kumar A, McIntosh L, Medhurst E, Saghebi J, Sandhu S, Murphy DG, Tran B, Azad AA, Hofman MS. Prognostic Value of Initial Imaging and PSA Change with [177Lu]Lu-PSMA-617 Radiopharmaceutical Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: A ProsTIC Registry Analysis. J Nucl Med. 2025 Dec 3;66(12):1914-1920. doi: 10.2967/jnumed.125.270804.

    PubMed 41067860

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

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 4 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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?

This study is still under way. Results are not available in the source record yet.

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?

PSA-RR (time frame: From baseline through to progression or death until registry completion (approx. 5 years).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04769817, which also lists 1 linked publication.

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 May 2026.

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