Using molecular markers to predict treatment response in advanced prostate cancer
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 (PSMA-PRED)
This study is testing if certain markers in tumor DNA can help doctors predict how well a new treatment for advanced prostate cancer will work for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre Jean Perrin Academic / other |
| Locations | 5 sites (Clermont-Ferrand and 4 other locations) |
| Trial ID | NCT06600802 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of 177Lutetium-PSMA-617 (Lu-PSMA) treatment for patients with castration-resistant metastatic prostate cancer by analyzing molecular markers in tumor DNA. The research will involve collecting blood samples and assessing the presence of specific biomarkers that may predict patient response to the treatment. The goal is to identify predictive factors that can help stratify patients based on their likelihood of benefiting from Lu-PSMA therapy. This approach seeks to improve treatment outcomes by personalizing therapy based on individual tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 18 years old with histologically confirmed metastatic castration-resistant prostate cancer who have previously received specific lines of therapy.
Not a fit: Patients who have not undergone prior treatment with taxanes or second-generation hormone therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with advanced prostate cancer by identifying those most likely to respond to Lu-PSMA therapy.
How similar studies have performed: Other studies have shown promising results in using molecular profiling to predict treatment responses in various cancers, suggesting potential success for this approach in prostate cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand and 4 other locations
- Centre Jean PERRIN — Clermont-Ferrand, France (Recruiting)
- CHU de Grenoble — La Tronche, France (Not_yet_recruiting)
- Hospices Civiles de Lyon — Pierre-Bénite, France (Not_yet_recruiting)
- Hôpital privé de la Loire — Saint-Etienne, France (Not_yet_recruiting)
- Centre Paul STRAUSS — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Judith PASSILDAS JAHANMOHAN, PhD
- Email: judith.passildas@clermont.unicancer.fr
- Phone: 0473278005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.