AzTrials
AzTrials

Prostate AdenocarcinomaPhase 2PREFAcENCT04391556

Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma

A Phase 2 study testing Firmagon in people with Prostate Adenocarcinoma, run by Centre Leon Berard at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
Firmagon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
6 sitesFrance
Study dates
14 Sep 2020to 3 Apr 2024
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old;
  • Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on at least two successive dosages in the last 12 months) OR Hormone-naive patients, initially treated curatively by external radiotherapy or by brachytherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed on at least two successive dosages in the last 12 months ) OR hormone-naive patients treated by surgery or external radiotherapy or brachytherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy or brachytherapy);
  • Diagnostic recurrence assessment by any information or examination carried out since the ascension of the PSA, not having revealed local recurrence or lymph node lesions which may benefit from to external radiation
  • Signed informed consent.

Who cannot join

  • Patient already treated by hormonotherapy;
  • Formal contraindication to hormonotherapy;
  • Formal contraindication to external radiotherapy
  • Formal contraindication to the Lasilix administration during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis patient and patient presenting a severe renal insufficiency (creatinine clearance <30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
  • Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc > 450 msecs according to Bazett formula;
  • Impossibility to comply with the study follow-up for geographical or psychic reasons.
  • Patient under protection of justice (Under tutorship, curatorship or deprived of liberty)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Chu Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier de Grenoble Hôpital Nord Michallon

    La Tronche, 38700

  • Centre Léon Bérard

    Lyon, 69008

  • APHM - Hôpital Nord

    Marseille, 13015

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

Other trials in France

About this study

Official title: Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment

Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment

Read the detailed description

The identification of lesions responsible for biological recurrence or persistent biological disease in patients with prostatic adenocarcinoma (PA) remains an outstanding problem due to the lack of sensitivity of standard imaging techniques. The efficacy of empirical radiation therapy of the prostate + pelvis zone in only half of patients with increased PSA suggests an underestimation of lesions.

PET-68Ga-PSMA or PET-PSMA technique showed a clear gain in sensitivity for the detection of lesions in this context compared to PET-Choline which was already more sensitive than standard imaging. It is about 50% for a PSA <0.5 ng / ml vs 20% for a PSA <1 ng / ml for TEP-Choline technique. However, the indication of empirical radiotherapy is raised when the PSA exceeds 0.2 ng / ml. It is therefore still necessary to increase the sensitivity of PET-PSMA.

A flare-up-related effect was observed in a small animal experiment and in a patient after androgen blocking treatment, inducing a sharp increase in the intensity of previously visualized lesions and the appearance of 13 new lesions.

It would therefore be possible to increase the expression of PSMA by the lesions at the origin of the biological recurrence of AP and thus to improve their detection by PET-PSMA after potentiation by short-term androgen blocking by an antagonist of LH-RH.

Being tested
Firmagon
Keywords
Prostate adenocarcinoma, TEP PSMA, Androgenic blockade

What participants receive

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

  • FirmagonDrug

    Also called Injection of Firmagon after a TEP-PSMA

    120 mg subcutaneous Injection of Firmagon after a TEP-PSMA

Study groups in NCT04391556
Study groupRoleWhat they receive
FirmagonExperimental120 mg Firmagon subcutaneous injection after a TEP-PSMA
Receives: Drug: Firmagon

What is being measured

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

  1. Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness

    PSMA-PET

    Measured: Day 14 after the androgenic blockade

Secondary outcomes (9)

  1. Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation

    PSMA-PET and PSMA-H-PET

    Measured: Day 14 after the androgenic blockade

  2. Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET

    Number of lesions (PSMA-ET and PSMA-H PET)

    Measured: Day 14 after the androgenic blockade

  3. Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET

    Fixation intensity (PSMA-ET and PSMA-H PET)

    Measured: Day 14 after the androgenic blockade

  4. Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications

    Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET

    Measured: Day 14 after the androgenic blockade

  5. Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection

    PSMA-PET and PSMA-H-PET efficience

    Measured: Day 14 after the androgenic blockade

  6. Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)

    PSMA-PET efficience

    Measured: Day 14 after the androgenic blockade

  7. Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)

    PSA rate

    Measured: Day 14 after the androgenic blockade

  8. Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results

    PSA and testosterone rates and PSMA-PET results

    Measured: Day 14 after the androgenic blockade

  9. Tolerance profile

    Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

    Measured: Up to Day 15-30 visit

Timeline

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

  1. First posted18 May 2020
  2. Study start14 Sep 2020
  3. Primary completion2 May 2023
  4. Study completion3 Apr 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391556
Sponsor's protocol ID
ET19-194 - PREFAcE
Acronym
PREFAcE
Status last verified
Apr 2025
First submitted
23 Apr 2020
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Firmagon in people with Prostate Adenocarcinoma, run by Centre Leon Berard at 6 sites in France.

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 7 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: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness (time frame: Day 14 after the androgenic blockade). 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 NCT04391556.

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 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in