Metastatic Castration-resistant Prostate Cancer (mCRPC)NCT04825652
177Lu-PSMA-617 Managed Access Program for mCRPC Patients
A study testing 177Lu-PSMA-617 and PSMA-11 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Advanced Accelerator Applications.
Trial summary
The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- 177Lu-PSMA-617 and PSMA-11
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years of age.
- Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
- Rising PSA according to PCWG3 criteria (2 rising values above a baseline at a minimum of 1-week intervals) and PSA ≥2.0 ng/mL
- Soft-tissue progression defined as per prostate cancer working group 3 (PCWG3)-modified RECIST v1.1
- Progression of bone disease as per PCWG3 criteria
- Patients must have mCRPC with histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
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- Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging.
- Patients must have prostate-specific membrane antigen (PSMA)- positive prostate cancer, as determined by PSMA-targeted PET / CT scan.
- Patients must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
- Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if:
- The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).
- Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
- Patients must have adequate organ function:
- Bone marrow reserve:
- White blood cell (WBC) count ≥ 2.5 x 10^9/L (2.5 × 10^9/L is equivalent to 2.5 × 10^3/μL and 2.5 × K/μL and 2.5 × 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1.5 × 10^9/L is equivalent to 1.5 × 10^3/μL and 1.5 × K/μL and 1.5 × 10^3/cumm and 1500/μL).
- Platelets ≥ 100 × 10^9/L (100 × 10^9/L is equivalent to 100 × 10^3/μL and 100 × K/μL and 100 × 10^3/cumm and 100 000/μL).
- Hemoglobin ≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L).
- Hepatic:
- Total bilirubin ≤ 1.5 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN OR ≤ 5.0 × ULN for patients with liver metastases.
- Renal:
- Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
- Albumin > 3.0 g/dL (3.0 g/dL is equivalent to 30 g/L).
Who cannot join
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as Lu-PSMA-617.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Transfusion for the sole purpose of making a subject eligible for study inclusion.
- Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
- Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
- Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions which could compromise safe participation in the MAP.
- Not able to understand and comply with treatment instructions and requirements.
About this study
Official title: Managed Access Program (MAP) Cohort Treatment Plan [CAAA617A12001M] to Provide Access to 177Lu-PSMA-617 for Patients With Metastatic Castration-resistant Prostate Cancer.
The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Read the detailed description
PSMA-11 will be provided in certain cases where it may be required as a diagnostic imaging agent. PSMA-11 is used to confirm the presence of PSMA positive lesions in patients, which then makes them eligible for treatment with 177Lu-PSMA-617.
- Being tested
- 177Lu-PSMA-617, PSMA-11
- Keywords
- metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-PSMA-617Drug
Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles.
PSMA-11Drug
Patients will receive a dose of gallium (68Ga) gozetotide that is 1.8-2.2 MBq/kg of body weight (0.049-0.059 mCi/kg), with a minimum dose of 111 MBq (3mCi) up to a maximum dose of 259 MBq (7 mCi).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825652
- Sponsor's protocol ID
- CAAA617A12001M
- Status last verified
- Jan 2023
- First submitted
- 29 Mar 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Program (MAP) Cohort Treatment Plan [CAAA617A12001M] to Provide Access to 177Lu-PSMA-617 for Patients With Metastatic Castration-resistant Prostate Cancer.
- ClinicalTrials.gov ID
- NCT04825652
- Acronym / sponsor ID
- CAAA617A12001M
- Keywords
- metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- First posted
- 1 Apr 2021 (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.
The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Detailed description
PSMA-11 will be provided in certain cases where it may be required as a diagnostic imaging agent. PSMA-11 is used to confirm the presence of PSMA positive lesions in patients, which then makes them eligible for treatment with 177Lu-PSMA-617.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must be ≥ 18 years of age.
- Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
- Patients must have mCRPC with histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging.
- Patients must have prostate-specific membrane antigen (PSMA)- positive prostate cancer, as determined by PSMA-targeted PET / CT scan.
Key exclusion criteria (7 listed)
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as Lu-PSMA-617.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Transfusion for the sole purpose of making a subject eligible for study inclusion.
- Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
- Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
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 |
|---|---|---|
| 177Lu-PSMA-617Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. | Drug | – |
| PSMA-11Patients will receive a dose of gallium (68Ga) gozetotide that is 1.8-2.2 MBq/kg of body weight (0.049-0.059 mCi/kg), with a minimum dose of 111 MBq (3mCi) up to a maximum dose of 259 MBq (7 mCi). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 177Lu-PSMA-617 and PSMA-11 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Advanced Accelerator Applications.
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 24 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 13 Jan 2023.