Status:
RECRUITING
Intrinsic Validity of Molecular Marker(s) Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 (Lu-PSMA) Treatment for Castration-resistant Metastatic Prostate Cancer
Lead Sponsor:
Centre Jean Perrin
Collaborating Sponsors:
GIRCI Auvergne Rhône-Alpes
Conditions:
Castration-resistant Metastatic Prostate Cancer
Treated by 177Lutetium-PSMA-617 (Lu-PSMA)
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Prostate cancer is the most common cancer in men. Its incidence is rising as the population ages. In the localized stage, the 5-year overall survival rate (OS) is 98%. Metastatic progression and resis...
Detailed Description
Prostate cancer is the most common cancer in men. Its incidence is rising as the population ages. In the localized stage, the 5-year overall survival rate (OS) is 98%. Metastatic progression and resis...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male \>18 years of age
- ECOG ≤ 2
- Patient with histologically confirmed of metastatic castration resistant prostatic adenocarcinoma and with tumor biological material available (prostatic biopsies or prostatectomy)
- Patient who received at least one taxane line and a second generation hormone therapy line
- Patient receiving androgen deprivation therapy with serum testosterone \< 50 ng/dL or \< 1.7 nmol/L or having undergone surgical castration
- Progressive mCRPC based based on at least 1 of the following criteria :
- Serum or plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week prior. The minimal start value is 2.0 ng/mL ; 1,0 ng/mL is the minimal start value if confirmed increase in PSA is the only indication of progress
- Soft-tissue progression by RECIST 1.1 criteria
- Progression of bone disease : two new lesions ; only the positivity of bone scan defines metastatic bone disease, according to PCWG3 criteria.
- Patients with at least one metastasis, bone and/or soft tissue and/or visceral, documented by the following methods in the 43 days prior to inclusion :
- Bone metastasis (regardless of location) highlighted by bone scan AND/OR
- Lymph nodes metastasis, regardless of size and location; if the metastasis are only lymph nodes, the short axis of at least one node should be at least 15 mm AND outside the pelvis ; AND/OR
- Visceral metastasis, regardless of size and location; a history of visceral metastasis at any time prior to randomization should be encoded as the presence of visceral metastasis at baseline (i.e., a patient with visceral metastasis prior ADT introduction which are disappeared at baseline will be counted as having visceral metastasis and will be considered to have a high tumor volume during stratification)
- Patient with Lu-PSMA treatment indication, confirmed by PET 68Ga-PSMA-11. Eligibility for 68Ga-PSMA-11 PET is defined as:
- At least one lesion with a binding intensity greater than that of the liver parenchyma (definition of positivity),
- All lymph node lesions larger than 25 mm in the short axis must be positive on PSMA PET
- All bone metastases with a soft tissue component ≥ 10 mm in the largest diameter must be positive on PSMA-PET
- All solid organ metastases (e.g., lung, liver, adrenal glands, etc.) ≥ 10 mm in the largest diameter must be positive on PSMA-PET.
- Adequate organ function :
- Bone marrow reserve :
- Absolute neutrophil count ≥ 1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L.
- Hemoglobin ≥ 9 g/dL
- Hepatic function :
- Total bilirubin ≤ 2 x the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤ 3 x ULN is permitted.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.
- Albumin \> 2.5 g/dL
- Renal function : Glomerular Filtration Rate (GFR) ≥ 50 mL/min/1.73m2 according to MDRD equation.
- Obtaining the patient's free and informed consent
- Social security scheme or beneficiary.
- Exclusion Criteria :
- Continuation of second-generation hormone therapy Patient
- Other cancer in the last 3 years likely to change life expectancy or interfere with the assessment of the disease
- Protected adult
- History of somatic or psychiatric illness/condition that may interfere with study objectives and evaluations
- Patient unable to understand and comply with study instructions and requirements
- ECOG \> 2
- Dilation of pyelocalicial cavities not previously supported
- Obstruction of bladder discharge or uncontrollable and simultaneous urinary incontinence
- Symptomatic spinal cord compression or clinical or radiological findings indicating imminent spinal cord compression
- Fractured risk of bone damage
- Active and symptomatic brain injury
- Concurrent participation in a therapeutic trial and administration of any investigational agent within 28 days of inclusion
- Metastatic tumor tissue as the only material available for prostate cancer diagnosis
- Previous treatment with any of the following in the 6 months prior to inclusion : Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-cyclic irradiation
- Previous treatment with radioligands targeting PSMA
- Known hypersensitivity to one of the study treatments or its excipients or similar class drugs
- Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for inclusion in the study
Exclusion
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2034
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06600802
Start Date
October 8 2024
End Date
June 30 2034
Last Update
December 31 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Jean PERRIN
Clermont-Ferrand, France, 63011
2
CHU de Grenoble
La Tronche, France, 38700
3
Hospices Civiles de Lyon
Pierre-Bénite, France, 69310
4
Hôpital privé de la Loire
Saint-Etienne, France, 42100