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Castration Resistant Prostatic CancerPhase 2GUIDENCT04918810

Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer

A Phase 2 study testing Docetaxel intermittent in people with Castration Resistant Prostatic Cancer, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 8 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration Resistant Prostatic Cancer
What is being tested?
Docetaxel intermittent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
8 sitesAustralia
Study dates
29 Jul 2022to 1 Nov 2024
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

PRESCREENING INCLUSION CRITERIA

  1. Patient has provided written informed consent using the GUIDE pre-screening PICF
  2. Age ≥ 18 years at the time of pre-screening consent
  3. Males with metastatic castration-resistant prostate cancer (as per PCWG3) AND are planned to commence docetaxel chemotherapy
  4. WHO Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 1)
  5. Histological confirmation of prostate cancer
  6. Patients must have adequate bone marrow and hepatic function within 14 days prior Cycle 1 day 1:
  • Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks)
  • Platelets ≥ 100 x 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN
  1. Willing and able to comply with all pre-screening study requirements, including blood tests for mGSTP1 analysis before and during docetaxel treatment

PRESCREENING EXCLUSION CRITERIA

  1. Prior docetaxel or cabazitaxel chemotherapy for castration-resistant prostate cancer
  2. Prior docetaxel in the castration sensitive prostate cancer setting within the previous 2 years
  3. Known hypersensitivity to docetaxel or its excipients
  4. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol

MAIN SCREENING INCLUSION CRITERIA

  1. Patient has provided written informed consent for the main GUIDE study PICF
  2. Patient has a detectable plasma mGSTP1 deoxyribonucleic acid (DNA) as measured by central laboratory at prescreening prior to commencing first cycle of docetaxel chemotherapy
  3. Patient has commenced 3 cycles of docetaxel
  4. Patient has undetectable plasma mGSTP1 DNA as measured by central laboratory from blood taken prior to the third cycle of docetaxel
  5. Patient is willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

MAIN SCREENING EXCCLUSION CRITERIA

  1. Known hypersensitivity to docetaxel or its excipients
  2. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  3. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  4. Progressive disease by RECIST 1.1 within the first 3 cycles of docetaxel

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Australia8 sites

  • Border Medical Oncology Research Unit / The Border Cancer Hospital

    Albury, New South Wales, 2460

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2021

  • Dubbo Base Hospital

    Dubbo, New South Wales, 2830

  • Frankston Hospital-Peninsula Health

    Frankston, Victoria, 3199

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • Concord Repatriation General Hospital

    Sydney, New South Wales

  • LaTrobe Regional Hospital

    Traralgon, Victoria, 3844

Other trials in Australia

About this study

Official title: A Phase II Trial of Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This study will tell us if having these treatment breaks guided by mGSTP1 can improve how people feel during treatment while still treating the prostate cancer effectively.

Docetaxel is a chemotherapy drug that is approved to treat prostate cancer and has been used for many years to treat prostate cancer like yours. Your doctor has already discussed this with you and you have both agreed that docetaxel is the best treatment for you to have at this time. You will have already started this chemotherapeutic treatment with docetaxel.

Being tested
Docetaxel intermittent
Keywords
mGSTPi
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel intermittentDrug

    After 3 or 4 cycles of docetaxel chemotherapy (75mg/m^2 every 21 days or 50mg/m^2 every 14 days) in combination with an undetectable mGSTP1 level, patients will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days or 28 days (depending on Docetaxel regimen) and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.

Study groups in NCT04918810
Study groupRoleWhat they receive
Arm 1: Intermittent docetaxel treatmentExperimentalsuspend docetaxel prior to cycle 4, recommencement based on mGSTP1 monitoring
Receives: Drug: Docetaxel intermittent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic progression free survival (rPFS)

    Radiographic progression free survival (rPFS) is defined as the time from enrollment (i.e. prior to cycle 4), the date of first documented progression on imaging by site investigator (PCWG3 criteria for bone lesions and RECIST 1.1 for soft tissue lesions) or death due to any cause.

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

Secondary outcomes (9)

  1. Time on treatment holidays

    Time on treatment holidays is defined as the total length of time patients on the intermittent docetaxel spend off docetaxel within the treatment period i.e. prior to permanent treatment discontinuation

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  2. Overall treatment safety

    Incidence and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.

    Measured: From the date of signing consent on the Main study until 90 days after the last day of protocol treatment, on average 3.5 years

  3. Overall survival

    Overall survival is defined as the time from enrollment to the date of death due to any cause

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  4. Overall quality of life

    Quality of Life using the EORTC QLQ-C30 (European Organisation for Research on Treatment of Cancer - Quality of Life Questionnaire for cancer patients) instrument.

    The instrument uses 28 questions about overall quality of life with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 28 indicating a better quality of life and higher scores with a maximum of 112 indicating lower overall quality of life.

    The questionnaire also has two summary questions which asks participants to rank 1) overall health and 2) overall quality of life on scale of from 1, very poor, to 7, excellent.

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  5. Fatigue

    Fatigue, using the EORTC FA-12 (European Organisation for Research on Treatment of Cancer - Fatigue) instrument.

    This instrument uses 12 questions for participants about fatigue with each question answerable on a scale of 1 (not at all) to 4 (Very Much) to a maximum score of 48 indicating worse overall self-rated fatigue.

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  6. Fear of progression

    Fear of progression using the short FOP12 (Fear of Progression) instrument.

    This instrument uses 12 questions about participant's own Fear of Progression with each question answerable using a scale from "Never" to "very often" with lower scores indicating a better outcome.

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  7. Patient reported adverse events

    Patient reported adverse events using the patient reported modified PRO-CTCAE instrument

    Measured: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

  8. Frequency of health resource utilisation

    To compare resource use associated with mGSTP1 directed therapy. Will be measured from trial based eCRFs and will include frequency of mGSTP1 testing, use of docetaxel and corticosteroids, pathology tests and imaging.

    People participating in the GUIDE study will be consented for access to their Medicare claims data providing information on outpatient use of PBS listed therapies (such as those for metastatic bone disease) and Medicare services (such as outpatient clinician services)

    Measured: From time of consent until End of Study, on average 3.5 years

  9. Overall cost associated with treatment

    To compare costs associated with treatment. Will be reported by type of health care used and the total cost of health care used over the period of the trial and follow-up.

    Market prices will be applied to items of resource use to estimate costs.

    Measured: From time of consent until End of Study, on average 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start29 Jul 2022
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Why it stopped: Recruitment lower than expected. The proportion of patients with mGSTPi undetectable prior to chemo. was significantly higher than anticipated. Decision made to close due to insufficient patient numbers to able to obtain meaningful data collection.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918810
Sponsor's protocol ID
ANZUP 1903
Acronym
GUIDE
Status last verified
Nov 2024
First submitted
26 May 2021
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel intermittent in people with Castration Resistant Prostatic Cancer, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 8 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment lower than expected. The proportion of patients with mGSTPi undetectable prior to chemo. was significantly higher than anticipated. Decision made to close due to insufficient patient numbers to able to obtain meaningful data collection.). 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.

What does the primary outcome measure?

Radiographic progression free survival (rPFS) (time frame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918810.

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 22 Nov 2024.

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