Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05340374
Registration number
NCT05340374
Ethics application status
Date submitted
14/04/2022
Date registered
22/04/2022
Date last updated
27/11/2023
Titles & IDs
Public title
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer
Query!
Scientific title
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer
Query!
Secondary ID [1]
0
0
21/018
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LuCAB
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer
0
0
Query!
mCRPC
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cabazitaxel
Treatment: Drugs - 177Lu-PSMA-617
Experimental: Treatment Arm - In this single-arm study, patients will receive 7.4 GBq of 177Lu-PSMA-617 on Day 1 of every 6 week Cycle. Cabazitaxel will be administered concurrently on Day 2 and Day 23 of each Cycle (every 3 weeks). The dose of cabazitaxel will vary in dose-escalation. Up to 6 Cycles will be given.
Treatment: Drugs: Cabazitaxel
Cabazitaxel belongs to the Taxane group of drugs which function by interfering with microtubule depolymerisation and thus inhibit mitosis, which leads to cell death via apoptosis. It is the first chemotherapy agent to improve survival in patients with mCRPC with progressive disease after docetaxel-based treatment.
Treatment: Drugs: 177Lu-PSMA-617
Lutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA which is expressed on the prostate cancer cell, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Multiple clinical trials have demonstrated high clinical activity and limited normal tissue toxicity using 177Lu-PSMA-617.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of participants with Dose Limiting Toxicities (DLTs)
Query!
Assessment method [1]
0
0
A DLT is defined as a toxicity that prevents further administration of the trial treatment at that dose level.
Each cohort of 3 patients be assessed for DLTs in the first 6 weeks (cycle 1) of treatment and a dose for the next cohort will be determined.
Query!
Timepoint [1]
0
0
Dose escalation phase is expected to be completed 9 months from the time the first patient is recruited.
Query!
Primary outcome [2]
0
0
Maximum Tolerated dose (MTD)
Query!
Assessment method [2]
0
0
The MTD is defined as the highest dose level at which the incidence of DLT was less than 2/6.
Query!
Timepoint [2]
0
0
Dose escalation phase is expected to be completed 9 months from the time the first patient is recruited.
Query!
Primary outcome [3]
0
0
Recommended Phase 2 Dose (RP2D)
Query!
Assessment method [3]
0
0
After the MTD is established, additional patients will be treated at the MTD. Safety and efficacy data from the study will be used to define the RP2D.
Query!
Timepoint [3]
0
0
Up to 30 months from the time the first patient is recruited.
Query!
Secondary outcome [1]
0
0
Adverse Events (AEs) and Serious Adverse Events (SAEs) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Query!
Assessment method [1]
0
0
Safety of the combination will be measured by AEs and SAEs.
Query!
Timepoint [1]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [2]
0
0
50% Prostate-Specific Antigen Response Rate (PSA-RR)
Query!
Assessment method [2]
0
0
PSA will be assessed at baseline and every 3 weeks from cycle 1 day 1. PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.
Query!
Timepoint [2]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [3]
0
0
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST1.1) in patients with measurable disease
Query!
Assessment method [3]
0
0
Objective Response (OR) is only applicable for the subset of patients with measurable disease by RECIST1.1. OR is defined as a partial response (PR) or complete response (CR) at any stage from time of commencement of protocol treatment to the time of subsequent systemic anti-cancer treatment. The ORR is calculated as the proportion of patients with a best response of CR or PR.
Query!
Timepoint [3]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [4]
0
0
Radiographic Progression-Free Survival (rPFS)
Query!
Assessment method [4]
0
0
rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per RECIST1.1 for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for bone lesions.
Query!
Timepoint [4]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [5]
0
0
PSA progression free survival (PSA-PFS)
Query!
Assessment method [5]
0
0
PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later.
Query!
Timepoint [5]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [6]
0
0
Overall survival (OS)
Query!
Assessment method [6]
0
0
OS is defined as the time from treatment initiation to the date of death due to any cause.
Query!
Timepoint [6]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Secondary outcome [7]
0
0
Describe pain within 12 months of treatment commencement
Query!
Assessment method [7]
0
0
Pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF). This form assesses pain at its "worst," "least," "average," and "now" (current pain) in a 24-hour period at different timepoints, using a scale from 0-10. A higher score indicates more severe pain. The primary endpoint is the area under the curve (AUC) obtained from repeated patient responses to the BPI-SF item concerning "worst pain" in 24 hours.
Pain will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals.
Query!
Timepoint [7]
0
0
Through completion of 12 months after treatment commencement of last patient
Query!
Secondary outcome [8]
0
0
Describe health-related quality of life (QoL) within 12 months of treatment commencement
Query!
Assessment method [8]
0
0
QoL will be assessed using the Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) questionnaire. The primary endpoint for QoL is the area under the curve (AUC) of the trial outcome index (TOI), which is the sum of the Functional Assessment of Cancer Therapy -General (FACT-G), physical well-being, functional well-being, and prostate cancer subscale (PCS) scores. The score ranges from 0-156. A higher score indicates better quality of life.
QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals.
Query!
Timepoint [8]
0
0
Through completion of 12 months after treatment commencement of last patient
Query!
Secondary outcome [9]
0
0
Rate of treatment discontinuation due to toxicity
Query!
Assessment method [9]
0
0
The percentage of patients who discontinue treatment due to treatment related toxicity will be reported.
Query!
Timepoint [9]
0
0
Through study completion, up until 24 months after the last patient commences treatment
Query!
Eligibility
Key inclusion criteria
1. Male patients aged 18 years or older at the time of informed consent.
2. Patient has provided written informed consent.
3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation.
4. Eastern Cooperative Oncology Group (ECOG) performance status of = 1
5. Patients must have had prior treatment with docetaxel.
6. Patients must have progressed on a second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, or apalutamide) in the castrate-resistant setting.
7. Patients must have progressive disease. The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) defines this as any one of the following:
1. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of = 1 week between each measurement
2. Soft tissue or visceral disease progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
3. Bone progression: = 2 new lesions on bone scan
8. At least three weeks since the completion of surgery prior to registration.
9. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
10. Serum testosterone levels = 1.75nmol/L within 28 days prior to registration.
11. Imaging evidence of metastatic disease documented with either whole body bone scan (WBBS) or computed tomography (CT) scan performed within 28 days prior to registration.
12. Significant prostate-specific membrane antigen (PSMA) avidity on PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease.
13. Patients must have a life expectancy = 12 weeks.
14. Assessed by a medical oncologist as suitable for treatment with cabazitaxel and 177Lu-PSMA-617.
15. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
1. Haemoglobin = 90 g/L independent of transfusions (no red blood cell transfusion in last 28 days prior to registration)
2. Absolute neutrophil count (ANC) = 1.5x10^9/L
3. Platelets = 150 x10^9/L
4. Total bilirubin = 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component
5. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN if there is no evidence of liver metastasis or = 5 x ULN in the presence of liver metastases
6. Albumin = 25 g/L
7. Adequate renal function: patients must have a creatinine clearance estimated of = 40 mL/min using the Cockcroft-Gault equation
16. Sexually active patients are willing to use medically acceptable forms of barrier contraception.
17. Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Superscan on WBBS or diffuse marrow disease on PSMA PET.
2. Site(s) of measurable disease that are FDG-positive with low PSMA expression (SUVmax <10).
3. Prior treatment with cabazitaxel or 177Lu-PSMA-617.
4. Contraindications to the use of corticosteroid treatment.
5. Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
6. Presence of untreated brain metastases or leptomeningeal metastases.
7. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for = four weeks.
8. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
9. Persistent toxicities (CTCAE v5.0 >/= Grade 2) caused by previous cancer therapy, excluding alopecia.
10. Known HIV or hepatitis B or C infection.
11. Radiotherapy or systemic anti-cancer therapies administered within 14 days prior to registration, excluding androgen deprivation therapy (ADT).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/07/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2026
Query!
Actual
Query!
Sample size
Target
44
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Peter MacCallum Cancer Centre, Australia
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05340374
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
A/Prof Arun Azad
Query!
Address
0
0
Peter MacCallum Cancer Centre, Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Gaurav Sharma
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
03 85596830
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05340374
Download to PDF