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AzTrials

Castration-resistant Prostate CancerPhase 2HiTeCHNCT03522064

Bipolar Androgen Therapy + Carboplatin in mCRPC

A Phase 2 study testing Testosterone Enanthate 100 MG/ML Injectable Solution and Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5 in people with Castration-resistant Prostate Cancer and Homologous Recombination Deficiency, run by St Vincent's Hospital, Sydney at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Testosterone Enanthate 100 MG/ML Injectable Solution and Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustralia
Study dates
30 Jul 2018to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Males with histologically confirmed adenocarcinoma of the prostate
  • Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.
  • Age ≥ 18 years
  • ECOG performance status ≤ 1
  • Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone
  • Serum testosterone < 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year.
Show all 14Show fewer
  • Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)
  • Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >100)
  • Adequate liver function (ALT/AST < 1.5 x ULN, bilirubin < 2 x ULN)
  • Adequate renal function (creatinine clearance > 50 ml/min)
  • Adequate cardiac function and reserve after cardiology assessment
  • Archived tissue sample available or willingness to undergo fresh biopsy
  • Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
  • Signed, written informed consent

Who cannot join

  • Contraindications to investigational product
  • Pain due to metastatic prostate cancer requiring opioid analgesics
  • Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).
  • Previous treatment with platinum chemotherapy and/or a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.
  • Life expectancy of less than 3 months.
  • Brain metastases or leptomeningeal disease
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  • History of thromboembolic event and not currently on anticoagulation
  • Prior myocardial infarction or unstable angina within 2 years of study entry
  • Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA >1)
  • History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
  • Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robert Kent contact

+61293555611

SVHS.CancerResearch@svha.org.au

Australia1 site, 1 recruiting

  • Kinghorn Cancer Centre, St. Vincent's Hospital

    Sydney, New South Wales, 2010

    Robert Kent, 0293555611, SVHS.CancerResearch@svha.org.au

    Recruiting

Other trials in Australia

About this study

Official title: High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer

The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).

Read the detailed description

Androgen deprivation therapy (ADT) remains the mainstay of prostate cancer treatment. Though an effective therapy initially, the side effects of ADT are numerous and treatment resistance is inevitable. Castrate-refractory prostate cancer (CRPC) progresses via adaptive mechanisms that allow ongoing androgen receptor (AR) signalling despite castrate levels of androgens.

The concept of cycling between supra- and sub physiological levels of testosterone has been tested recently in studies of "bipolar androgen therapy" (BAT) in which patients are given high dose testosterone in combination with androgen deprivation therapy (ADT) via an LHRH agonist/antagonist. Studies of BAT using IM testosterone have been promising both in terms of PSA responses and quality of life improvements. Additionally, these early phase studies suggest the potential for re-sensitisation to novel anti-androgen therapies.

Though responses have been positive in these early studies a proportion of men fail to respond and data to guide patient selection is lacking. There are data to suggest that patients with DNA repair deficits may be particularly responsive to BAT. Whether these changes serve as predictors of response is unknown as the effect of BAT on the tumour, its microenvironment and peripheral circulating tumour DNA has not been studied in detail. Information on treatment effects may be key to appropriate patient selection for this treatment.

The aim of this study is to assess based on the pre-clinical studies, the combination with carboplatin

Being tested
Testosterone Enanthate 100 MG/ML Injectable Solution, Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5
Keywords
Castrate-resistant prostate cancer, bipolar androgen therapy, homologous recombination deficiency, BRCA

What participants receive

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

  • Testosterone Enanthate 100 MG/ML Injectable SolutionDrug

    Also called Primoteston Depot

    Testosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL.

  • Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5Drug

    Testosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL. Carboplatin as per standard procedures

Study groups in NCT03522064
Study groupRoleWhat they receive
High dose testosterone + CarbolplatinExperimental500mg IM enanthate every 4 weeks in combination with ongoing LHRH agent (unless post-orchidectomy) plus Carboplatin AUC 5
Receives: Drug: Testosterone Enanthate 100 MG/ML Injectable Solution; Drug: Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5

What is being measured

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

  1. PSA Response Rate

    >/= 50% fall from baseline PSA

    Measured: 1 year

Secondary outcomes (3)

  1. Time to PSA progression

    Time to increase in PSA >/=25% from baseline or nadir confirmed on subsequent test >1 week later

    Measured: 1 year

  2. Radiological Response Rate

    RECIST or PCWG3 Criteria

    Measured: 1 year

  3. Safety and Tolerability (Frequency of adverse events as assessed by NCI CTCAE v4.0)

    Frequency of adverse events as assessed by NCI CTCAE v4.0

    Measured: 1 year

Timeline

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

  1. First posted11 May 2018
  2. Study start30 Jul 2018
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522064
Sponsor's protocol ID
HiTECH
Acronym
HiTeCH
Status last verified
May 2025
First submitted
17 Apr 2018
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teply BA, Wang H, Luber B, Sullivan R, Rifkind I, Bruns A, Spitz A, DeCarli M, Sinibaldi V, Pratz CF, Lu C, Silberstein JL, Luo J, Schweizer MT, Drake CG, Carducci MA, Paller CJ, Antonarakis ES, Eisenberger MA, Denmeade SR. Bipolar androgen therapy in men with metastatic castration-resistant prostate cancer after progression on enzalutamide: an open-label, phase 2, multicohort study. Lancet Oncol. 2018 Jan;19(1):76-86. doi: 10.1016/S1470-2045(17)30906-3. Epub 2017 Dec 14.

    PubMed 29248236

  • Schweizer MT, Wang H, Luber B, Nadal R, Spitz A, Rosen DM, Cao H, Antonarakis ES, Eisenberger MA, Carducci MA, Paller C, Denmeade SR. Bipolar Androgen Therapy for Men With Androgen Ablation Naive Prostate Cancer: Results From the Phase II BATMAN Study. Prostate. 2016 Sep;76(13):1218-26. doi: 10.1002/pros.23209. Epub 2016 Jun 24.

    PubMed 27338150

  • Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

    PubMed 32203306

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone Enanthate 100 MG/ML Injectable Solution and Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5 in people with Castration-resistant Prostate Cancer and Homologous Recombination Deficiency, run by St Vincent's Hospital, Sydney at 1 site in Australia.

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

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert Kent (+61293555611, SVHS.CancerResearch@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA Response Rate (time frame: 1 year). 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 NCT03522064, which also lists 3 linked publications.

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 23 Apr 2026.

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