Current partner codePEPTIDESDE
NCT04391556·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

57

Locations

6

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Firmagon

120 mg subcutaneous Injection of Firmagon after a TEP-PSMA

Timeline

From registration to results.

  1. First posted

    May 18, 2020

  2. Study start

    Sep 14, 2020

  3. Primary completion

    May 2, 2023

  4. Study completion

    Apr 3, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 14, 2025

Outcomes

What the study measures.

Primary outcomes

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

PSMA-PET

Secondary outcomes

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

Time frame · Day 14 after the androgenic blockade

PSMA-PET and PSMA-H-PET

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

Time frame · Day 14 after the androgenic blockade

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

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

Time frame · Day 14 after the androgenic blockade

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

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

Time frame · Day 14 after the androgenic blockade

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

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

Time frame · Day 14 after the androgenic blockade

PSMA-PET and PSMA-H-PET efficience

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)

Time frame · Day 14 after the androgenic blockade

PSMA-PET efficience

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)

Time frame · Day 14 after the androgenic blockade

PSA rate

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

Time frame · Day 14 after the androgenic blockade

PSA and testosterone rates and PSMA-PET results

Tolerance profile

Time frame · Up to Day 15-30 visit

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Study locations

6 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Chu Gabriel Montpied

Clermont-Ferrand, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier de Grenoble Hôpital Nord Michallon

La Tronche, France

Centre Léon Bérard

Lyon, France

APHM - Hôpital Nord

Marseille, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.