Prostate CancerADTPSMA2NCT03876912
The Effect of ADT on PSMA Expression in Metastatic Prostate Cancer
A study testing GnRH antagonist in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GnRH antagonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2019to 1 Mar 2023
- Phase
- Interventional
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Previous PC treatment
- Uncontrolled serious infection
- Prior usage of 5-ARI medication in past 12 months
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20500
Simona Malaspina, MD, +35823138122, simona.malaspina@tyks.fi
Otto Ettala, PhD, +35823130280, otto.ettala@tyks.fi
About this study
Official title: The Effect of Androgen Deprivation Therapy on the Expression of Prostate Specific Membrane Antigen (PSMA) Evaluated With 18F-PSMA PET/CT in Treatment naïve Metastatic Prostate Cancer Patients
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- GnRH antagonist
- Keywords
- Prostate Specific Membrane Antigen, GnRH antagonist, Positron Emission Tomography, PSMA-PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonistDrug
Also called Degarelix
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.
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist | Experimental | Administration of GnRH antagonist (subcutaneous injection, 240 mg) after baseline 18F-PSMA 1007 PET/CT.Then 18F-PSMA 1007 PET/CT is repeated 3 weeks after ADT and at development of CRPC Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSMA-flare after ADT
Comparison of mean increase of SUVmax in 18F-PSMA 1007 PET between bone lesions and prostatic lesions after the initiation of ADT
Measured: 2-3 weeks
Secondary outcomes (1)
PSMA-flare in the follow-up until CRPC
Compare SUVmax of lesions with PSMA flare and those without during the follow-up and at CRPC
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jukka Kemppainen, Adj.Prof., Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876912
- Sponsor's protocol ID
- ADTPSMA2
- Acronym
- ADTPSMA2
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malaspina S, Ettala O, Tolvanen T, Rajander J, Eskola O, Bostrom PJ, Kemppainen J. Flare on [18F]PSMA-1007 PET/CT after short-term androgen deprivation therapy and its correlation to FDG uptake: possible marker of tumor aggressiveness in treatment-naive metastatic prostate cancer patients. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):613-621. doi: 10.1007/s00259-022-05970-y. Epub 2022 Sep 26.
PubMed 36161511
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Androgen Deprivation Therapy on the Expression of Prostate Specific Membrane Antigen (PSMA) Evaluated With 18F-PSMA PET/CT in Treatment naïve Metastatic Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03876912
- Acronym / sponsor ID
- ADTPSMA2 / ADTPSMA2
- Conditions
- Prostate Cancer
- Keywords
- Prostate Specific Membrane Antigen, GnRH antagonist, Positron Emission Tomography, PSMA-PET/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 15 Mar 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist | Experimental | Drug: GnRH antagonistAdministration of GnRH antagonist (subcutaneous injection, 240 mg) after baseline 18F-PSMA 1007 PET/CT.Then 18F-PSMA 1007 PET/CT is repeated 3 weeks after ADT and at development of CRPC |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Previous PC treatment
- Uncontrolled serious infection
- Prior usage of 5-ARI medication in past 12 months
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 |
|---|---|---|
| GnRH antagonistAlso: Degarelix18F-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. | Drug | GnRH antagonist |
Primary outcome
PSMA-flare after ADT
Time frame: 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
1 secondary outcome
PSMA-flare in the follow-up until CRPC
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 36161511Malaspina S, Ettala O, Tolvanen T, Rajander J, Eskola O, Bostrom PJ, Kemppainen J. Flare on [18F]PSMA-1007 PET/CT after short-term androgen deprivation therapy and its correlation to FDG uptake: possible marker of tumor aggressiveness in treatment-naive metastatic prostate cancer patients. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):613-621. doi: 10.1007/s00259-022-05970-y. Epub 2022 Sep 26.
- 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.
Jukka Kemppainen, Adj.Prof. principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH antagonist in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Malaspina, MD (+35823138122, simona.malaspina@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSMA-flare after ADT (time frame: 2-3 weeks). 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 NCT03876912, 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 13 Apr 2021.