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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04343885




Registration number
NCT04343885
Ethics application status
Date submitted
1/04/2020
Date registered
13/04/2020

Titles & IDs
Public title
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
Scientific title
UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
Secondary ID [1] 0 0
19/195
Universal Trial Number (UTN)
Trial acronym
UpFrontPSMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone Naive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 177Lu-PSMA-617
Treatment: Drugs - Docetaxel

Experimental: 177Lu-PSMA+ Docetaxel - 7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles

Other: Docetaxel (Control) - Docetaxel 75 mg/m2 every 3 weeks x 6 cycles


Treatment: Drugs: 177Lu-PSMA-617
Patients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles.

Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
Timepoint [1] 0 0
Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.
Secondary outcome [1] 0 0
Safety of 177Lu-PSMA followed by docetaxel compared to docetaxel alone
Timepoint [1] 0 0
Through completion of treatment, maximum 26 months.
Secondary outcome [2] 0 0
Time to development of castration resistance between treatment Arms
Timepoint [2] 0 0
Through study completion, up until 2 years after the last patient commences treatment.
Secondary outcome [3] 0 0
PSA-progression free survival (PSA-PFS) between treatment Arms
Timepoint [3] 0 0
Through study completion, up until 2 years after the last patient commences treatment.
Secondary outcome [4] 0 0
Radiographic-PFS (rPFS) between treatment Arms
Timepoint [4] 0 0
Through study completion, up until 2 years after the last patient commences treatment.
Secondary outcome [5] 0 0
Early PSMA PET response between treatment Arms
Timepoint [5] 0 0
Through completion of 3 months after treatment commencement for last patient, maximum 23 months.
Secondary outcome [6] 0 0
Describe and compare health-related QoL within 12 months of treatment commencement between treatment Arms
Timepoint [6] 0 0
Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Secondary outcome [7] 0 0
Describe and compare pain within 12 months of treatment commencement between treatment Arms
Timepoint [7] 0 0
Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Secondary outcome [8] 0 0
Overall survival (OS) between treatment Arms
Timepoint [8] 0 0
Through study completion, up until 2 years after the last patient commences treatment.

Eligibility
Key inclusion criteria
Inclusion Criteria for study registration:

1. Patient has provided written informed consent
2. Male aged 18 years or older at screening
3. Prostate cancer diagnosed within 12 weeks of commencement of screening
4. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA
5. Evidence of metastatic disease on CT and/or bone scan
6. PSA > 10ng/ml prior to commencement of medical ADT or surgical orchidectomy
7. Adequate haematological, renal and hepatic functions as defined by:

* Absolute neutrophil count >1.5 x 109/L
* Platelet count >100 x 109/L
* Haemoglobin = 90g/L (no red blood cell transfusion in 4 weeks prior to randomisation)
* Creatinine Clearance = 40mL/min (Cockcroft-Gault formula)
* Total bilirubin < 1.5 x ULN (unless known or suspected Gilbert syndrome)
* Aspartate transaminase (AST) or alanine transaminase (ALT) = 2.0 x ULN (or = 5.0 x ULN in the presence of liver metastases)
8. Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1)
9. Life expectancy greater than 6 months with treatment
10. Assessed by a medical oncologist as suitable for treatment with docetaxel
11. Patients must agree to use an adequate method of contraception
12. Willing and able to comply with all study requirements, including all treatments and required assessments including follow-up
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Registration:

1. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:

* Up to 4 weeks of ADT with luteinising hormone releasing hormone agonists or antagonists or orchiectomy ± concurrent anti-androgens are permitted prior to commencement of screening. At investigator discretion, patients may start ADT at commencement of protocol therapy
* Up to one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 14 days prior to registration
2. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
3. Central nervous system metastases
4. Patients with Sjogren's syndrome
5. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
6. Prior diagnosis of another cancer that was:

* More than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence greater than 10%
* Within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)

Inclusion Criteria for Randomisation:

1. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease
2. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or = 4 bone metastases with = 1 outside the vertebral column and pelvis (extra-axial skeleton)
3. Patient continues to meet all the inclusion criteria for registration

Exclusion Criteria for Randomisation:

1. Major FDG-PET discordance defined as presence of FDG positive disease with minimal PSMA expression in multiple sites (>5) or in more than 50% of total disease volume
2. All the exclusion criteria for registration continue to not apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Royal North Shore - St Leonards
Recruitment hospital [3] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [4] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [9] 0 0
Austin Health - Melbourne
Recruitment hospital [10] 0 0
Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
3084 - Melbourne
Recruitment postcode(s) [10] 0 0
3000 - Prahran
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Movember Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Prostate Cancer Research Alliance
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
United States Department of Defense
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Advanced Accelerator Applications
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Australia's Nuclear Science and Technology Organisation (ANSTO)
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Australasian Radiopharmaceutical Trials network (ARTnet)
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Centre for Biostatistics and Clinical Trials (BaCT)
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arun Azad, MBBS PhD FRACP
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04343885