The WOMBAT study will test if BAT can prolong the time it takes for nmCRPC prostate cancer to become detectable in other areas of the body (metastatic disease). Approximately 69 participants over the age of 18 with castrate resistant prostate cancer, no evidence of metastatic disease (M0) on conventional imaging (WBBS and CT scan at screening) and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia. Participants will receive continuous androgen deprivation therapy with LHRH agonists/antagonists. The study intervention will be IM testosterone enthanate, injected on day 1 of each 56-day cycle. Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle. Both LHRH and agonist/antagonist and darolutamide are supplied through the PBS as standard of care medications. Administration of both testosterone and darolutamide will continue until disease progression, beyond disease progression, unacceptable toxicity, death, withdrawal of consent or study Sponsor termination of the study. Primary objective (endpoint) is to determine the metastasis-free survival (time from commencing BAT to evidence of metastases or death)
This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer. Adults with castrate resistant prostate cancer, with no evidence of metastatic disease (M0) on conventional imaging \[Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening\] and prostate specific antigen (PSA) only progression on darolutamide may be eligible. Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment. It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Testosterone enanthate is a depot formulation used in Australia typically for androgen replacement in people with confirmed testosterone deficiency.
The Canberra Hospital
Garran, Australian Capital Territory, Australia
RECRUITINGThe Border Cancer Hospital
Albury, New South Wales, Australia
TERMINATEDSt Vincents Hospital
Darlinghurst, New South Wales, Australia
RECRUITINGGenesisCare North Shore
St Leonards, New South Wales, Australia
RECRUITINGSydney Adventist Hospital
Wahroonga, New South Wales, Australia
RECRUITINGICON Cancer Centre
Chermside, Queensland, Australia
RECRUITINGMater Misericordiae Ltd - QLD
South Brisbane, Queensland, Australia
NOT_YET_RECRUITINGRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGGrampians Health
Ballarat, Victoria, Australia
RECRUITINGEastern Health - Box Hill
Box Hill, Victoria, Australia
RECRUITING...and 2 more locations
Metastases free survival
Based on PCWG3 criteria (appendix 2) and/or RECIST1.1 (appendix 1) on CT and WBBS imaging.
Time frame: From date of commencing Bipolar Androgen Therapy (BAT) until first documented evidence of metastatic disease or date of death, assessed every 8 weeks, on average 4 years
Safety and tolerability of BAT + darolutamide
The safety and tolerability of BAT + darolutamide (Incidence and grade of AEs by NCI CTCAE v5.0 Common Terminology Criteria for Adverse Events will be used to grade and classify adverse events after each cycle. Adverse events will be reported as all grade, grade 3-4, grade 5 and Adverse events of special interest (related to bipolar androgen therapy).
Time frame: Continuously throughout the study, from time of commencing BAT until 30 days after last dose of treatment
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-C30
Using the European Organisation for Research Treatment of Cancer (EORTC) quality of life (QOL) questionnaire QLQ-C30. QLQ-C30 uses 28 questions about overall QOL 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 QOL and higher scores with a maximum of 112 indicating lower overall QOL. It has two summary questions which asks participants to rank, 1) overall health and 2) overall QOL on scale from 1: very poor, to 7; excellent.
Time frame: During screening and then every 2 weeks upon commencement of BAT for 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years.
The effect of BAT + darolutamide on Health-related Quality of Life QLQ-PR25
Using the European Organisation for Research Treatment of Cancer (EORTC) quality of life (QOL) questionnaire QLQ-PR25. QLQ-PR25 is a supplement to QLQ-C30 and designed to assess symptoms related to prostate cancer, treatment, and aspects of life related to prostate cancer.QLQ-PR25 uses 25 questions about overall QOL with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 25 indicating a better QOL and higher scores with a maximum of 100 indicating lower overall QOL.
Time frame: During screening and then every 2 weeks upon commencement of BAT for 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years.
PSA response rate to BAT + darolutamide
By testing PSA level in blood. PSA response rate is defined as a PSA reduction of \>=50% from baseline as per PCWG3 criteria
Time frame: During screening and then every 2 weeks from the time of commencing BAT for first 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years
Time to PSA progression on BAT + darolutamide
By testing PSA level in blood. PSA progression is defined as a PSA increase of \>=25% from baseline or nadir, confirmed on subsequent test \>=1 week later as per PCWG3)
Time frame: During screening and then every 2 weeks from the time of commencing BAT for first 8 weeks and then every 4 weeks until last dose of treatment, on average 2 years
PSA and hormone kinetics in response to BAT + darolutamide. This will be assessed as a composite outcome.
Blood tests assessing change in PSA, testosterone, oestradiol, Dihydrotestosterone (DHT), Dehydroepiandrosterone (DHEA), sex hormone-binding globulin (SBHG)
Time frame: Every 2 weeks for first 24 weeks from the time of commencing BAT
The effect of BAT + darolutamide on metabolic and bone turnover markers and bone mineral density. This will be assessed as a composite outcome.
Testing bone turnover markers via serum procollagen type I N propeptide (PINP) and plasma C-terminal cross-linking telopeptide of type I collagen (CTX). Bone densitometry imaging.
Time frame: Serum/plasma/urine - at screening and at 6 and 12 months on treatment. Bone densitometry imaging - at screening and 12 months on treatment.
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