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Trial registered on ANZCTR


Registration number
ACTRN12621000747820
Ethics application status
Approved
Date submitted
7/12/2020
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
TaxAdapt: A clinical trial testing the feasibility, acceptability, and safety of docetaxel in men with prostate cancer that has spread
Scientific title
TaxAdapt: Feasibility, acceptability and safety of adaptive dosing of docetaxel in men with metastatic castrate-resistant prostate cancer
Secondary ID [1] 301359 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TaxAdapt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castration-resistant prostate cancer 317589 0
Condition category
Condition code
Cancer 315670 315670 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men consenting to take treatment with EVIQ standard dose docetaxel (75mg/m2 intravenously every three weeks) for mCRPC will be registered, and enrolled and enter adaptive loops of therapy if they experience 50% or more decline of their PSA (i.e. patients that suffer primary resistance will not be eligible to continue). When the PSA blood test falls by more than 50%, docetaxel will then be stopped. Ongoing three-weekly reviews and PSA blood tests we be attended. The participant will be advised to re-initiate docetaxel when the PSA level has reached the pre-treatment/baseline PSA level. E.g. if a man's PSA is 80 at the time of starting docetaxel, falls below 40 and he paused docetaxel treatment, then three-weekly visits and PSA blood tests will occur; when the man's blood test rises back to 80 or higher, he will be offered to restart the docetaxel. This "loop" of patient-individualised precision adaptive therapy will be repeated for as long as there is ongoing patient consent, tolerance and safety (i.e. repeated re-response). Each time docetaxel is stopped, it will be defined as the start of a new adaptive therapy cycle (a “loop”). This "loop" of patient-individualised precision adaptive therapy will be repeated indefinitely for as long as there is ongoing patient consent, tolerance and safety (i.e. repeated re-response). While the clinical trial will have a maximum of 24 months of follow-up for each participant, if the adaptive loops of therapy are continuing to control a participant's cancer after the end of follow-up for an individual participant, the participant and their clinician may choose to continue this strategy of dosing off-study. A maximum of 10 cycles of docetaxel will be offered as per EVIQ protocol.
Intervention code [1] 319251 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325939 0
Tolerability and acceptability of adaptively dosed docetaxel. Tolerability will be assessed as the number of men that are able to complete at least 3 adaptive loops of treatment divided by the number of men that are enrolled on study. Acceptability will be assessed as the number of men who consent to the study divided by the number of patient information consent forms offered to potentially eligible participants.
Timepoint [1] 325939 0
The outcome of the study will be assessed at the time of the end of the third adaptive loop of treatment in the last patient enrolled on study
Secondary outcome [1] 389607 0
2. Safety as defined by adverse events (CTCAE v5.0)
Timepoint [1] 389607 0
2. Continuous during study treatment and for 30 days after the end of treatment
Secondary outcome [2] 389608 0
3. Efficacy of adaptively dose docetaxel will be as defined as the frequency of PSA response/re-response after docetaxel re-introduction in each loop; i.e the frequency of adaptive loops in each man on study where the PSA falls by 50%
Timepoint [2] 389608 0
3. PSA blood tests will be taken every 3 weeks until the end of treatment
Secondary outcome [3] 389609 0
4. Efficacy as defined by radiological response per PCWG3 criteria
Timepoint [3] 389609 0
4. Three monthly CT and bone scans until end of treatment or end of study
Secondary outcome [4] 389610 0
5. Efficacy as defined by median time to on-treatment failure on docetaxel defined by PCWG3 criteria
Timepoint [4] 389610 0
5. At each treatment loop, each 3 monthly scan or at end of study

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
· Histologically or biochemically confirmed adenocarcinoma of the prostate
· Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration with testosterone at screening <0.5 ng/L) (NB Patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial)
· Metastatic castration resistant prostate cancer (CRPC)
· Controlled symptoms (opioids for cancer related pain stable for > 4 weeks, no need for urgent radiotherapy for symptomatic lesions)
· Metastatic disease defined as at least 1 documented metastatic lesion on either a whole body bone scan or a CT scan of the chest, abdomen and pelvis.
· Participant has chosen to take enzalutamide as standard of care treatment for CRPC
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
· Prior treatment with taxane chemotherapy, (e.g. docetaxel and/or cabazitaxel)
· Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
· Known or suspected brain metastasis or active leptomeningeal disease;
· Any other therapies for CRPC (excluding denosumab) to be discontinued 3 weeks prior to study.
· Prior treatments with CYP17 or androgen receptor inhibitors (abiraterone or enzalutamide prior to this course). Prior treatment with docetaxel or cabazitaxel is allowed.
· Documented liver metastases

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis
The safety population will comprise all participants who received at least one administration of study medication. All safety analyses will be performed on the Safety Population. The analysis of safety data will be principally descriptive in nature. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be tabulated by treatment allocation and CTCAE criteria including system organ class, term, and worst grade.
All efficacy analyses will be performed on the Safety Population. Efficacy analyses will be primarily descriptive for this safety and feasibility study. The primary efficacy analysis will measure PSA-progression free survival. Point estimates for time-to-event endpoints will estimated using the Kaplan-Meier method with appropriate confidence intervals. Kaplan-Meier curves will be produced to summarise the distribution of the time-to-event data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
7/07/2022
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18161 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 32158 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 305799 0
Charities/Societies/Foundations
Name [1] 305799 0
Below the Belt Pedalthon
Country [1] 305799 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Edith St, Waratah, NSW 2298
Country
Australia
Secondary sponsor category [1] 306237 0
None
Name [1] 306237 0
Address [1] 306237 0
Country [1] 306237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306070 0
Hunter New England Local Health District Human Research Ethics Committee
Ethics committee address [1] 306070 0
Ethics committee country [1] 306070 0
Australia
Date submitted for ethics approval [1] 306070 0
17/06/2020
Approval date [1] 306070 0
25/09/2020
Ethics approval number [1] 306070 0
20/06/17/3.01

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

Contacts
Principal investigator
Name 102594 0
A/Prof Craig Gedye
Address 102594 0
Calvary Mater Newcastle, Edith St, Waratah, NSW 2298
Country 102594 0
Australia
Phone 102594 0
+61 2 4921 1211
Fax 102594 0
Email 102594 0
craig.gedye@calvarymater.org.au
Contact person for public queries
Name 102595 0
Craig Gedye
Address 102595 0
Calvary Mater Newcastle, Edith St, Waratah, NSW 2298
Country 102595 0
Australia
Phone 102595 0
+61 2 4921 1211
Fax 102595 0
Email 102595 0
craig.gedye@calvarymater.org.au
Contact person for scientific queries
Name 102596 0
Craig Gedye
Address 102596 0
Calvary Mater Newcastle, Edith St, Waratah, NSW 2298
Country 102596 0
Australia
Phone 102596 0
+61 2 4921 1211
Fax 102596 0
Email 102596 0
craig.gedye@calvarymater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study with small patient numbers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.