Clinical trial NCT04918810: Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer
Official title: A Phase II Trial of Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Castration Resistant Prostatic Cancer
Keywords: mGSTPi
Lead sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Sponsor class: OTHER
Collaborators: name: Peter MacCallum Cancer Centre, Australia
First posted: 2021-06-09
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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
7. 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

Primary outcomes:
measure: Radiographic progression free survival (rPFS)
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcomes:
measure: Time on treatment holidays
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Overall treatment safety
timeFrame: 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
measure: Overall survival
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Overall quality of life
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Fatigue
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Fear of progression
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Patient reported adverse events
timeFrame: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
measure: Frequency of health resource utilisation
timeFrame: From time of consent until End of Study, on average 3.5 years
measure: Overall cost associated with treatment
timeFrame: From time of consent until End of Study, on average 3.5 years
Other outcomes:
Locations:
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit / The Border Cancer Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Dubbo
country: Australia
facility: Dubbo Base Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital-Peninsula Health
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Traralgon
country: Australia
facility: LaTrobe Regional Hospital
state: Victoria
Study officials:
affiliation: Chris Obrien Lifehouse
name: Kate Mahon
role: PRINCIPAL_INVESTIGATOR
References: