Prostate Cancer
Conditions
Keywords
Prostate Specific Membrane Antigen, GnRH antagonist, Positron Emission Tomography, PSMA-PET/CT
Brief summary
Thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18F-PSMA 1007 PET/CT at baseline, 3 weeks after the initiation of GnRH-antagonist, at one year and at the time of castration resistant prostate cancer (CRPC). The aim of the study is to classify metastatic lesions into those with PSMA-flare and those without and determine their potential to progress during the follow-up until CRPC.
Detailed description
In metastatic prostate cancer androgen deprivation therapy (ADT) has been traditionally used as a first line approach. Based on histological studies, animal models and PSMA-PET imaging, it is known that administration of ADT increases prostate specific membrane antigen (PSMA) expression. Preliminary results of our previous prospective clinical trial (clinicaltrials.gov identifier: NCT03313726) with nine men demonstrated a heterogenous flare in PSMA expression 2-3 weeks after ADT, more evidently in bone metastases. Our hypothesis is that metastatic lesions having PSMA-flare respond differently to ADT and have different outcome than those without PSMA-flare. Therefore, the objective of the study is to demonstrate the PSMA-flare seen in bone lesions 3 weeks after ADT and then determine the potential predictive value of the phenomenon in the progression to castration resistant prostate cancer (CRPC). Thirty-five men with newly diagnosed, metastatic PC will undergo 18F-PSMA 1007 PET/CT before and 3 weeks after the initiation of sub-cutaneous injection of GnRH-antagonist (Degarelix, Firmagon®). A subgroup of 20 patients will receive an additional FDG PET/CT scan before ADT to investigate whether lesions with PSMA flare show a different metabolic behaviour on FDG PET. During the follow-up, 18F-PSMA 1007 PET/CT will be also performed once a year. Finally all patients will repeat 18F-PSMA 1007 PET/CT at the time of CRPC. In addition to imaging, PSA is measured, and blood drawn for androgen levels and biomarkers in three months interval.
Interventions
DRUGGnRH antagonist
18F-PSMA 1007 PET/CT before, 3 weeks after ADT, at 1 year and at CRPC in 35 patients. 18F-FDG PET/CT in a subgroup of 20 patients before ADT.
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age: 40 to 85 years old * Language spoken: Finnish * Diagnosis: Histologically confirmed adenocarcinoma of prostate * Adequate histological sampling consisting of at least 3 biopsy samples from each lobe * No previous surgical, radiation or endocrine treatment for prostate carcinoma * Clinical stage:T1c-T4NanyM1 * Serum creatinine ≤ 1,5 x ULN * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff
Exclusion criteria
* Previous PC treatment * Uncontrolled serious infection * Prior usage of 5-ARI medication in past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSMA-flare after ADT | 2-3 weeks | Comparison of mean increase of SUVmax in 18F-PSMA 1007 PET between bone lesions and prostatic lesions after the initiation of ADT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSMA-flare in the follow-up until CRPC | 2-3 years | Compare SUVmax of lesions with PSMA flare and those without during the follow-up and at CRPC |
Countries
Finland
Contacts
Primary ContactSimona Malaspina, MD
Backup ContactOtto Ettala, PhD
Outcome results
None listed