Prostate CancerADTPSMANCT03313726
The Effect of ADT on PSMA-PET.
A study testing GnRH antagonist in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
Trial summary
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 20 Sep 2017to 30 Sep 2018
- 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-T4N0-2M0-1 (arm, A); T1c-T3NxMx (arm, B)
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- Serum creatinine ≤ 1,5 x ULN
- Patient agrees to undergo surgery (arm, B)
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Who cannot join
- Infections: Patient must not have an uncontrolled serious infection
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Prior usage of 5-ARI medication in past 12 months
- Patient preference for active surveillance as a method of prostate cancer management
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20520
Jukka Kemppainen, MD, PhD, +358-2-3130196, jukka.kemppainen@tyks.fi
Otto Ettala, MD, PhD, +358-2-3130280, otto.ettala@tyks.fi
About this study
Official title: The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT.
Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.
Read the detailed description
Positron emission tomography has been commonly and successfully used, in combination with CT and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging is essential to guide the treatment options, which usually are radical prostatectomy or radiotherapy in localized prostate cancer or hormonal treatment in patients with metastasized disease, patients with hormonal relapse after radical radiotherapy or as an adjuvant treatment together with radiotherapy.
The use of PET imaging increases the sensitivity in the evaluation of lymph node involvement, as almost 80% of metastatic lymph nodes in prostate cancer are smaller than the threshold size usually measured with CT or MRI.
Nowadays new specific receptor targeted PET tracers in prostate cancer imaging has been introduced. One of the most used is 68Ga-PSMA that evaluates the expression of prostate-specific membrane antigen. This tracer has been rapidly taken into account for its better sensitivity and specificity in prostate cancer staging compared to the lipid metabolism tracers, like 11C/18F labeled fluorocholine or 11C-acetate.
In the recent literature it has been demonstrated for the first time on humans that PSMA expression, imaged with 68Ga-PSMA-11-PET, has increased in a patient with metastatic prostate cancer after androgen deprivation therapy (ADT).
These findings suggest that the use of hormonal therapy can affect the expression of PSMA and our hypothesis is that ADT therapy could increase the sensitivity of 68Ga-PSMA PET to detect nodal or distant metastasis in patients with prostate cancer. This prospective study consists in two phases. In phase A, 5 patients with newly diagnosed high risk prostate cancer with PSMA-positive nodal or distant metastasis screened by 68Ga-PSMA-11 PET/MRI, are given androgen deprivation therapy (ADT) with GNRH antagonist. After ADT therapy initiation, 68Ga-PSMA-11 PET/MRI is repeated at 7, 14 and 30 days to determine the highest PSMA expression based on SUVmax measurement.
In phase B, 20 high risk prostate cancer patients determined to undergo radical prostatectomy are screened with 68Ga-PSMA-11 PET/MRI, and then given GNRH antagonist therapy. 68Ga-PSMA-11 PET/MRI is repeated at the time of maximum PSMA expression based on phase A results. The patients then undergo radical prostatectomy and lymphadenectomy and imaging findings are matched with histological data.
- Conditions
- Prostate Cancer
- Being tested
- GnRH antagonist
- Keywords
- PSMA-PET
- 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
Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.
GnRH antagonistDrug
Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.
| Study group | Role | What they receive |
|---|---|---|
| GnRh-antagonist A | Experimental | Not described Receives: Drug: GnRH antagonist |
| GnRh-antagonist B | Experimental | Not described Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
GnRh-antagonist, A
Maximum SUV in PSMA-PET
Measured: 0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, B
Sensitivity and specificity of pre and post ADT 68Ga-PSMA-11 PET/MRI and standard clinical MRI using histology as a reference
Measured: 0 and 7, 14 or 28 days after ADT initiation according to phase A
Secondary outcomes (4)
GnRh-antagonist, A
Testosterone level (nmol/l)
Measured: 0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, A
PSA level (ug/l)
Measured: 0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, B
Testosterone level (nmol/l)
Measured: 56 and 112 days after ADT initiation
GnRh-antagonist, B
EPIC-questionnaire total and hormonal score
Measured: 56 and 112 days after ADT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start20 Sep 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313726
- Sponsor's protocol ID
- T83/2017
- Acronym
- ADTPSMA
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ettala O, Malaspina S, Tuokkola T, Luoto P, Loyttyniemi E, Bostrom PJ, Kemppainen J. Prospective study on the effect of short-term androgen deprivation therapy on PSMA uptake evaluated with 68Ga-PSMA-11 PET/MRI in men with treatment-naive prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):665-673. doi: 10.1007/s00259-019-04635-7. Epub 2019 Dec 26.
PubMed 31879814
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03313726
- Acronym / sponsor ID
- ADTPSMA / T83/2017
- Conditions
- Prostate Cancer
- Keywords
- PSMA-PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 18 Oct 2017 (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.
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT.
Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.
Detailed description
Positron emission tomography has been commonly and successfully used, in combination with CT and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging is essential to guide the treatment options, which usually are radical prostatectomy or radiotherapy in localized prostate cancer or hormonal treatment in patients with metastasized disease, patients with hormonal relapse after radical radiotherapy or as an adjuvant treatment together with radiotherapy.
The use of PET imaging increases the sensitivity in the evaluation of lymph node involvement, as almost 80% of metastatic lymph nodes in prostate cancer are smaller than the threshold size usually measured with CT or MRI.
Nowadays new specific receptor targeted PET tracers in prostate cancer imaging has been introduced. One of the most used is 68Ga-PSMA that evaluates the expression of prostate-specific membrane antigen. This tracer has been rapidly taken into account for its better sensitivity and specificity in prostate cancer staging compared to the lipid metabolism tracers, like 11C/18F labeled fluorocholine or 11C-acetate.
In the recent literature it has been demonstrated for the first time on humans that PSMA expression, imaged with 68Ga-PSMA-11-PET, has increased in a patient with metastatic prostate cancer after androgen deprivation therapy (ADT).
These findings suggest that the use of hormonal therapy can affect the expression of PSMA and our hypothesis is that ADT therapy could increase the sensitivity of 68Ga-PSMA PET to detect nodal or distant metastasis in patients with prostate cancer. This prospective study consists in two phases. In phase A, 5 patients with newly diagnosed high risk prostate cancer with PSMA-positive nodal or distant metastasis screened by 68Ga-PSMA-11 PET/MRI, are given androgen deprivation therapy (ADT) with GNRH antagonist. After ADT therapy initiation, 68Ga-PSMA-11 PET/MRI is repeated at 7, 14 and 30 days to determine the highest PSMA expression based on SUVmax measurement.
In phase B, 20 high risk prostate cancer patients determined to undergo radical prostatectomy are screened with 68Ga-PSMA-11 PET/MRI, and then given GNRH antagonist therapy. 68Ga-PSMA-11 PET/MRI is repeated at the time of maximum PSMA expression based on phase A results. The patients then undergo radical prostatectomy and lymphadenectomy and imaging findings are matched with histological data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRh-antagonist A | Experimental | Drug: GnRH antagonist |
| GnRh-antagonist B | Experimental | Drug: GnRH antagonist |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 (4 listed)
- Infections: Patient must not have an uncontrolled serious infection
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Prior usage of 5-ARI medication in past 12 months
- Patient preference for active surveillance as a method of prostate cancer management
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 antagonistAdministration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max. | Drug | GnRh-antagonist A |
| GnRH antagonistAdministration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding. | Drug | GnRh-antagonist B |
Primary outcome
GnRh-antagonist, A
Time frame: 0, 7, 14 and 28 days after ADT initiation
Maximum SUV in PSMA-PET
GnRh-antagonist, B
Time frame: 0 and 7, 14 or 28 days after ADT initiation according to phase A
Sensitivity and specificity of pre and post ADT 68Ga-PSMA-11 PET/MRI and standard clinical MRI using histology as a reference
4 secondary outcomes
GnRh-antagonist, A
Time frame: 0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, A
Time frame: 0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, B
Time frame: 56 and 112 days after ADT initiation
GnRh-antagonist, B
Time frame: 56 and 112 days after ADT initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Derived from this study: PubMed 31879814Ettala O, Malaspina S, Tuokkola T, Luoto P, Loyttyniemi E, Bostrom PJ, Kemppainen J. Prospective study on the effect of short-term androgen deprivation therapy on PSMA uptake evaluated with 68Ga-PSMA-11 PET/MRI in men with treatment-naive prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):665-673. doi: 10.1007/s00259-019-04635-7. Epub 2019 Dec 26.
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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.
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 10 inclusion and 4 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 18 Oct 2017. 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 Jukka Kemppainen, MD, PhD (+358-2-3130196, jukka.kemppainen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GnRh-antagonist, A (time frame: 0, 7, 14 and 28 days after ADT initiation). The study lists 2 primary outcomes in all. 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 NCT03313726, 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 18 Oct 2017.