Castration-resistant Metastatic Prostate CancerPSMA-PREDNCT06600802
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
A study testing Blood samples in people with Castration-resistant Metastatic Prostate Cancer and Treated by 177Lutetium-PSMA-617 (Lu-PSMA), run by Centre Jean Perrin at 5 sites in France.
Trial 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 resistance to castration have a negative impact on prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Metastatic Prostate Cancer, Treated by 177Lutetium-PSMA-617 (Lu-PSMA)
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Oct 2024to 30 Jun 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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 :
Show all 30Show fewer
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Jean PERRIN
Clermont-Ferrand, 63011
Judith PASSILDAS JAHANMOHAN, PhD, 0473278005, judith.passildas@clermont.unicancer.fr
Tressie HERRMANN, Dr
- Not yet recruiting
CHU de Grenoble
La Tronche, 38700
Loic DJAILEB, Dr
- Not yet recruiting
Hospices Civiles de Lyon
Pierre-Bénite, 69310
Denis MAILLET, Dr
- Not yet recruiting
Hôpital privé de la Loire
Saint-Etienne, 42100
Aline GUILLOT, Dr
- Not yet recruiting
Centre Paul STRAUSS
Strasbourg, 67091
Francois SOMME, Dr
About this study
Official title: 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)
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 resistance to castration have a negative impact on prognosis. Despite recent advances in management, the 5-year OS is around 30%. Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy. These treatments have improved OS and progression-free survival (PFS). They are now used as standard therapy.
More recently, the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 (Lu-PSMA) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
Read more
This treatment is currently available in early access in France. Despite encouraging results, 40% of patients will not respond to Lu-PSMA, and there are currently no validated predictive factors. Studies are currently on going, but the identification of biomarkers seems necessary to better stratify risk in these patients.
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind. At present, molecular profiling is not a routine technique for prostate cancer, as it is for other solid cancers. At an early stage, the Decipher® Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data.
According to recent studies, methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets.
In the metastatic phase, certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors.
Molecular analysis (mutations, copy number alterations, gene expression, DNA methylation) could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA.
If reliable molecular abnormalities are identified on tissue, a diagnostic technique based on circulating tumor DNA (ctDNA) analysis will be useful in decision-making for these patients. A biological collection will therefore be created during the course of this study, with a view to using ctDNA analysis in subsequent research.
Read the 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 resistance to castration have a negative impact on prognosis. Despite recent advances in management, the 5-year OS is around 30%. Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy. These treatments have improved OS and progression-free survival (PFS). They are now used as standard therapy.
More recently, the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 (Lu-PSMA) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
This treatment is currently available in early access in France. Despite encouraging results, 40% of patients will not respond to Lu-PSMA, and there are currently no validated predictive factors. Studies are currently on going, but the identification of biomarkers seems necessary to better stratify risk in these patients.
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind. At present, molecular profiling is not a routine technique for prostate cancer, as it is for other solid cancers. At an early stage, the Decipher® Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data.
According to recent studies, methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets.
In the metastatic phase, certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors.
Molecular analysis (mutations, copy number alterations, gene expression, DNA methylation) could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA.
If reliable molecular abnormalities are identified on tissue, a diagnostic technique based on circulating tumor DNA (ctDNA) analysis will be useful in decision-making for these patients. A biological collection will therefore be created during the course of this study, with a view to using ctDNA analysis in subsequent research.
This is an interventional, multi-center study. The study is prospective, single-arm, open-label and non-randomized.
Its primary objective is to identify biomarkers of interest, in primary tissue, predictive of response to Lu-PSMA treatment in patients with mCRPC, through the detection of molecular abnormalities in DNA/RNA and methyloma.
- Conditions
- Castration-resistant Metastatic Prostate Cancer, Treated by 177Lutetium-PSMA-617 (Lu-PSMA)
- Being tested
- Blood samples
- Keywords
- mCRPC, Lu-PSMA, biomarkers, response, prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
A total of 3 blood samples (2 tubes of 9mL each) are added. The first sample will be taken at the inclusion visit, the 2nd at the end of the 2nd treatment cycle and the last at the end of Lu-PSMA treatment.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Genetic analysis will be conducted on intial tumor sample in order to identify biomarkers Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular abnormalities retained on primary tumor sample predicting response to Lu-PSMA in metastatic castration resistant prostate cancer patients assessed according to RECIST 1.1 and/or PCWG3 criteria
Biological interpretation and response to Lu-PSMA treatment on bone scan and CT scan according to RECIST 1.1 and/or PCWG3 criteria
Measured: From enrollment to 24 months after Lu-PSMA treatment
Secondary outcomes (9)
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without radiological progression
Radiological progression free survival defined as the duration between the start date of treatment and the date of the first progression of the disease according to criteria RECIST V1.1 and criteria PCWG3; or the date of death whatever the cause.
Measured: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without biological progression
Biological progression free survival defined as the duration between the start date of treatment and the date of the first PSA progression
Measured: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without clinical progression
Clinical progression free survival, definieds as the duration between the treatment start date and the date of the first clinical progression
Measured: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and overall survival
Overall survival definied as the time interval between the start date of treatment and the date of death whatever the cause
Measured: From enrollement to the end of the study, up to 58 months
Correlation between the biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and adverse effects during treatment.
Toxicities related to treatment of grade 3 or higher according to CTCAE v. 5.0 and any EIG
Measured: From enrollment to the end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of clinical characteristics improves biomarker performance
Performance status (0 to 4), pain and adverse events evaluations as assessed by CTCAE v4.0
Measured: From enrollement to end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of radiological characteristics improves biomarker performance
Radiological evaluation as assessed by RECIST criteria V1.1 and PCWG3 criteria
Measured: From enrollement to end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of biological characteristics improves biomarker performance
Biological evaluation as assessed with PSA level
Measured: From enrollement to end of Lu-PSMA treatment, up to 58 months
Biological interpretation and response to Lu-PSMA treatment on PET scan
Radiological progression free survival defined as the duration between the start date of treatment according to RECIP 1.0 criteria for patients who underwent 68Ga-PSMA-11 PET scans
Measured: From enrollment to 24 months after Lu-PSMA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024
- Primary completion30 Jun 2034 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600802
- Sponsor's protocol ID
- 2024-A00246-41
- Acronym
- PSMA-PRED
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06600802
- Acronym / sponsor ID
- PSMA-PRED / 2024-A00246-41
- Conditions
- Castration-resistant Metastatic Prostate Cancer, Treated by 177Lutetium-PSMA-617 (Lu-PSMA)
- Keywords
- mCRPC, Lu-PSMA, biomarkers, response, prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Jun 2034 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 19 Sep 2024 (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.
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 resistance to castration have a negative impact on prognosis. Despite recent advances in management, the 5-year OS is around 30%. Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy. These treatments have improved OS and progression-free survival (PFS). They are now used as standard therapy.
More recently, the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 (Lu-PSMA) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
This treatment is currently available in early access in France. Despite encouraging results, 40% of patients will not respond to Lu-PSMA, and there are currently no validated predictive factors. Studies are currently on going, but the identification of biomarkers seems necessary to better stratify risk in these patients.
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind. At present, molecular profiling is not a routine technique for prostate cancer, as it is for other solid cancers. At an early stage, the Decipher® Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data.
According to recent studies, methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets.
In the metastatic phase, certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors.
Molecular analysis (mutations, copy number alterations, gene expression, DNA methylation) could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA.
If reliable molecular abnormalities are identified on tissue, a diagnostic technique based on circulating tumor DNA (ctDNA) analysis will be useful in decision-making for these patients. A biological collection will therefore be created during the course of this study, with a view to using ctDNA analysis in subsequent research.
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 resistance to castration have a negative impact on prognosis. Despite recent advances in management, the 5-year OS is around 30%. Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy. These treatments have improved OS and progression-free survival (PFS). They are now used as standard therapy.
More recently, the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 (Lu-PSMA) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
This treatment is currently available in early access in France. Despite encouraging results, 40% of patients will not respond to Lu-PSMA, and there are currently no validated predictive factors. Studies are currently on going, but the identification of biomarkers seems necessary to better stratify risk in these patients.
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind. At present, molecular profiling is not a routine technique for prostate cancer, as it is for other solid cancers. At an early stage, the Decipher® Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data.
According to recent studies, methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets.
In the metastatic phase, certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors.
Molecular analysis (mutations, copy number alterations, gene expression, DNA methylation) could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA.
If reliable molecular abnormalities are identified on tissue, a diagnostic technique based on circulating tumor DNA (ctDNA) analysis will be useful in decision-making for these patients. A biological collection will therefore be created during the course of this study, with a view to using ctDNA analysis in subsequent research.
This is an interventional, multi-center study. The study is prospective, single-arm, open-label and non-randomized.
Its primary objective is to identify biomarkers of interest, in primary tissue, predictive of response to Lu-PSMA treatment in patients with mCRPC, through the detection of molecular abnormalities in DNA/RNA and methyloma.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Biological: Blood samplesGenetic analysis will be conducted on intial tumor sample in order to identify biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Blood samplesA total of 3 blood samples (2 tubes of 9mL each) are added. The first sample will be taken at the inclusion visit, the 2nd at the end of the 2nd treatment cycle and the last at the end of Lu-PSMA treatment. | Biological | Interventional |
Primary outcome
Molecular abnormalities retained on primary tumor sample predicting response to Lu-PSMA in metastatic castration resistant prostate cancer patients assessed according to RECIST 1.1 and/or PCWG3 criteria
Time frame: From enrollment to 24 months after Lu-PSMA treatment
Biological interpretation and response to Lu-PSMA treatment on bone scan and CT scan according to RECIST 1.1 and/or PCWG3 criteria
9 secondary outcomes
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without radiological progression
Time frame: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without biological progression
Time frame: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and survival without clinical progression
Time frame: From enrollment to 24 months after Lu-PSMA treatment
Correlation between biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and overall survival
Time frame: From enrollement to the end of the study, up to 58 months
Correlation between the biomarker(s) (molecular abnormalities retained on primary tumor sample for the first outcome measure) and adverse effects during treatment.
Time frame: From enrollment to the end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of clinical characteristics improves biomarker performance
Time frame: From enrollement to end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of radiological characteristics improves biomarker performance
Time frame: From enrollement to end of Lu-PSMA treatment, up to 58 months
Assess whether consideration of biological characteristics improves biomarker performance
Time frame: From enrollement to end of Lu-PSMA treatment, up to 58 months
Biological interpretation and response to Lu-PSMA treatment on PET scan
Time frame: From enrollment to 24 months after Lu-PSMA treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Castration-resistant Metastatic Prostate Cancer and Treated by 177Lutetium-PSMA-617 (Lu-PSMA), run by Centre Jean Perrin at 5 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 30 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith PASSILDAS JAHANMOHAN, PhD (0473278005, judith.passildas@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular abnormalities retained on primary tumor sample predicting response to Lu-PSMA in metastatic castration resistant prostate cancer patients assessed according to RECIST 1.1 and/or PCWG3 criteria (time frame: From enrollment to 24 months after Lu-PSMA treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.