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Prostate CancerPhase 2ExBATNCT04558866

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

A Phase 2 study testing Testosterone Cypionate and Darolutamide in people with Prostate Cancer, run by Latin American Cooperative Oncology Group at 6 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Testosterone Cypionate and Darolutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
6 sitesBrazil
Study dates
9 Jun 2021to 2 Apr 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

Who may be able to join

  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
  • Male aged 18 years and above.
  • Histologic confirmation of adenocarcinoma of the prostate.
  • Evidence of M1 metastatic disease (as defined by AJCC criteria) on previous bone, CT, and/or MRI scan.
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (ie, surgical or medical castration) confirmed by testosterone level below 50 ng/dL at the screening visit. Castrate levels of testosterone must be maintained by surgical or medical means (luteinizing hormone-releasing hormone [LHRH]/ GnRH analogues) throughout the conduct of the study.
  • Documented prostate cancer progression as per PCWG3 criteria1-3 with at least one of the following:
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  • PSA progression: defined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 2 ng/mL.* Participants who received an anti-androgen must have progression after withdrawal (4 weeks since last flutamide, bicalutamide or nilutamide administration)
  • Radiographic disease progression in soft tissue based on RECIST 1.1 criteria. Participants whose disease spread is limited to regional pelvic lymph nodes will be considered eligible.
  • Radiographic disease progression in bone defined as appearance of 2 or more new bone lesions on bone scan.
  • ECOG performance status 0-1.
  • Participants who are chemotherapy-naive for mCRPC who have received prior treatment with abiraterone acetate for advanced prostate cancer (M1 castration-sensitive or M1 castration-resistant settings). Abiraterone should be stopped at least 14 days prior to study treatment initiation.
  • Participants already receiving agents for the management of skeletal-related events (SREs) are allowed to continue with anti-bone resorptive therapy (including, but not limited to bisphosponate or receptor activator of nuclear factor kappa ligand inhibitor) if on stable dose for more than 28 days prior to treatment arm assignment.
  • Prior prostate cancer vaccine therapy, radiation therapy, radium-223, anti-androgens (eg, flutamide), ketoconazole, and diethylstilbestrol (DES) or other estrogens, are allowed up to 28 days prior to study arm assignment.
  • Asymptomatic or minimally symptomatic mCRPC according to Brief Pain Inventory - Short Form (BPI-SF) performed during screening: asymptomatic is defined as BPI-SF item #3 score of 0 to 1; minimally symptomatic is defined as BPI-SF item #3 score of 2 to 4.
  • Patients must agree to refrain from donating sperm during the course of this study and for at least 1 week after completion of study therapy.
  • Sexually active male subjects with female partners of childbearing potential must agree to use an adequate method of contraception as outlined in "Section 5.3.4 Contraception" during the course of the study treatment with Darolutamide and for 1 week after last dose.
  • Sufficient tumor tissue obtained prior to enrollment from a metastatic tumor lesion or from a primary tumor lesion (formalin fixed paraffin-embedded [FFPE] block or unstained tumor tissue sections). Tumor sample may be from core biopsy, punch biopsy, excisional biopsy, or surgical specimen). For patients without an available archival sample prior to study entry, enrolment without tissue provision will be allowed.

Who cannot join

  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast.
  • Participants with active brain metastases. Participants with brain metastases are eligible to enroll in this study if brain metastases have been treated and there is no magnetic resonance imaging (MRI except where contraindicated in which CT scan is acceptable) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration.
  • Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment.
  • Prior chemotherapy for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥ 12 months elapsed from last dose of docetaxel.
  • Prior treatment with enzalutamide, apalutamide, darolutamide or any 2nd generation anti-androgen for prostate cancer.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing quality of life questionnaires.
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  • Participants with serious or uncontrolled medical disorders that, in the opinion of the investigator, would impair the ability of the participant to receive protocol therapy or obscure the interpretation of AEs.
  • Patients who are unable to swallow oral medications.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of acute myocardial infarction (AMI), cerebrovascular accident and/or coronary artery stent or bypass surgery within 6 months of study entry.
  • Gastrointestinal disorders likely to interfere with absorption of the study medication.
  • History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place.
  • Uncontrolled hypertension despite medical management as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at the screening visit. Patients may be re-screened after adjustments of anti- hypertensive medications.
  • Inadequate organ function and laboratory tests as follows:
  • WBC < 2.0 x 109/L; Neutrophils < 1.5 x 109/L; Platelets <100x109/L; Hemoglobin < 9.0 g/dL (no history of red blood cell transfusion within 4 weeks prior to study entry).
  • Serum creatinine > 2x ULN unless creatinine clearance ≥ 40 mL/min (measured or calculated using the Cockroft-Gault formula).
  • AST or ALT: > 3.0 x ULN; Total bilirubin >1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0x ULN).
  • History of allergy or hypersensitivity to study drug components.
  • Any psychological, familial, sociological, or geographical condition that may hamper compliance with the protocol and follow-up.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Brazil6 sites

  • Hospital Sírio-Libanês DF

    Brasília, Federal District, 70.200-730

  • HMV - Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90.035-000

  • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)

    Rio de Janeiro, Rio de Janeiro, 22.250-905

  • Hospital São Rafael - Oncologia D'Or BA

    Salvador, Estado de Bahia, 41.253-190

  • Hospital Sírio-Libanês SP

    São Paulo, São Paulo, 01.308-050

  • HIAE - Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05.653-000

Other trials in Brazil

About this study

This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC).

Read the detailed description

This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after abiraterone. Extreme androgen therapy will include alternating 56-day cycles of darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days followed by testosterone cypionate 400 mg i.m. During the treatment period, patients will be followed with chest, abdomen and pelvis CT and bone scan every 8-9 weeks until cycle 4 and every 12 weeks thereafter during the study period. Patients who present with disease progression but are considered to be benefiting from the treatment may continue receiving it, but will be followed by their treating physician according to local guidelines (follow-up period). All patients who stopped treatment will enter follow-up period and survival data will be collected from medical charts. Additionally, QoL questionnaires (BPI-SF, EQ-5D-3L and FACT-P) will be applied every 8-9 weeks until the end of treatment.

Conditions
Prostate Cancer
Being tested
Testosterone Cypionate, Darolutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Testosterone CypionateDrug

    Also called Deposteron

    One administration every 63 cycles until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.

  • DarolutamideDrug

    Also called Nubeqa

    During 4 weeks, from day 29 to day 56 of each 63-day cycle (+- 3 days) until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.

Study groups in NCT04558866
Study groupRoleWhat they receive
ExBAT ArmExperimentalTestosterone Cypionate 400 mg IM on Day 1 and Darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days, from day 29 to day 56 followed by a washout period of 7 days (63-day cycles), until loss of benefit (disease progression and/or limiting toxicity).
Receives: Drug: Testosterone Cypionate; Drug: Darolutamide

What is being measured

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

  1. Rate of Radiographic Progression-Free Survival (rPFS)

    Defined as (at least one of the 3 criteria below):

    • Bone progression according to the Prostate Cancer Working Group 3 (PCWG3):
    • The first bone scan with ≥2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline);
    • The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).
    • Progression of soft tissue lesions measured by CT or MRI as defined in modified RECIST criteria.
    • •Death from any cause. The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).

    Measured: 12 months

Secondary outcomes (8)

  1. PSA decline ≥ 50% rate from baseline (PSA50)

    Defined as a decrease in the PSA ≥ 50% compared to the baseline value, confirmed by a second measurement at least 4 weeks apart. Patients will perform PSA test on Day 1 and Day 29 of each cycle during the study.

    Measured: 54 weeks

  2. Time to disease progression

    Defined as the time from Cycle 1 Day 1 of therapy to the date of first PSA, Clinical or Radiographic progression, whichever comes first. Patients not experiencing PSA, clinical or radiographic progression as of database cut-off, whether or not surviving, will be censored at the last assessment. The PSA progression will be defined as per PCWG3 guidelines: for patients showing an initial decline in PSA from baseline, is defined as an increase in PSA that is ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value at least 4 weeks later (i.e. aconfirmed rising trend). For patients with no decline in PSA from baseline, is defined as an increase in PSA that is ≥ 25% and ≥ 2 ng/mL after 12 weeks.

    Measured: 54 weeks

  3. Radiographic progression-free survival (rPFS)

    Defined as the time of the first dose to objective clinical or radiographic tumor progression as defined by PCWG3 for progressive disease or death. Progression will be assigned to the earliest observed time. Patients whose disease has not progressed at follow-up will be censored at the date when the last tumor assessment determined a lack of progression.

    Measured: 54 weeks

  4. Overall survival (OS)

    Defined as the time from Cycle1 Day 1 to date of death due to any cause. Patients who are still alive or who are lost to survival follow-up as of database cut-off date will be censored at the last known alive date on or prior to database cut-off date.

    Measured: 54 weeks

  5. Quality of life (QoL) - EQ-5D-3L

    QoL will be assessed using EQ-5D 3 level version [EQ-5D-3L] questionnaire. Summary statistics of the scores will be reported at baseline, and then on Day 1 of each cycle (+- 7 days), while the patient is on the study up to 54 weeks.

    Measured: 54 weeks

  6. Quality of life (QoL) - FACT-P

    QoL will be assessed using Functional Assessment of Cancer Therapy- Prostate [FACT-P] questionnaire. Summary statistics of the scores will be reported at baseline, and then on Day 1 of each cycle (+- 7 days), while the patient is on the study up to 54 weeks.

    Measured: 54 weeks

  7. Quality of life (QoL) - BPI-SF

    QoL will be assessed using Brief Pain Inventory-Short Form [BPI-SF]) questionnaire. Summary statistics of the scores will be reported at baseline, and then on Day 1 of each cycle (+- 7 days), while the patient is on the study up to 54 weeks.

    Measured: 54 weeks

  8. Frequency and severity of adverse events

    Incidence of adverse events (based on CTCAE Version 5) summarized by system organ class and/or preferred term, severity and relation to study treatment.

    Measured: Until 28 days after treatment discontinuation

Timeline

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

  1. First posted22 Sep 2020
  2. Study start9 Jun 2021
  3. Primary completion28 Mar 2023
  4. Study completion2 Apr 2024

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558866
Sponsor's protocol ID
LACOG 0620
Acronym
ExBAT
Status last verified
Aug 2026
First submitted
11 Sep 2020
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
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 Testosterone Cypionate and Darolutamide in people with Prostate Cancer, run by Latin American Cooperative Oncology Group at 6 sites in Brazil.

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 17 inclusion and 19 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: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of Radiographic Progression-Free Survival (rPFS) (time frame: 12 months). 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 NCT04558866.

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 28 Aug 2026.

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