Clinical trial NCT04769817: ProsTIC Registry of Men Treated With PSMA Theranostics
Official title: Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Keywords: Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Theranostic
177Lu-PSMA
Radionuclide Therapy
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with mCRPC who have progressed after novel anti-androgen therapy and taxane chemotherapy (unless unfit and symptomatic).

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

1. Diagnosis of mCRPC
2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
3. 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
4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines

Primary outcomes:
measure: PSA-RR
timeFrame: From baseline through to progression or death until registry completion (approx. 5 years).
Secondary outcomes:
measure: 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
timeFrame: From date of treatment to 12 weeks after completing study treatment.
measure: Radiographic progression-free survival (rPFS)
timeFrame: From date of treatment through to progression or death until registry completion (approx. 5 years).
measure: PSA progression free survival (PSA-PFS)
timeFrame: From date of treatment through to progression or death until registry completion (approx. 5 years).
measure: Overall survival (OS)
timeFrame: From date of treatment, up until 18 months after the last patient commences treatment.
measure: EORTC QLQ-C30
timeFrame: From baseline through to progression or death until registry completion (approx. 5 years).
measure: PPI
timeFrame: From baseline through to progression or death until registry completion (approx. 5 years).
Other outcomes:
measure: Prognostic and predictive value of baseline PET/CT
timeFrame: Baseline PSMA and FDG PET/CT within 3 months of 177Lu-PSMA therapy.
measure: Prognostic value of 12 week restaging PSMA and FDG PET/CT
timeFrame: 12 weeks after first cycle of 177Lu-PSMA therapy.
measure: Histopathology parameters
timeFrame: At baseline, 12 weeks post treatment and date of progression.
measure: Tumour DNA ± tumour tissue
timeFrame: At baseline, 12 weeks post treatment and date of progression.
measure: Whole blood RNA (androgen receptor splice variants)
timeFrame: At baseline, 12 weeks post treatment and date of progression.
measure: Whole blood RNA (TMPRSS2:ERG fusion gene)
timeFrame: At baseline, 12 weeks post treatment and date of progression.
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
References: