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Androgen deprivation therapy

Phase 2

Prostatic Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Jan 13, 2020

Target and mechanism

ModalitySmall molecule

Also known as Androgen Deprivation Therapy (ADT), Androgen-deprivation Therapy (ADT), Androgen-deprivation Therapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Androgen deprivation therapy · 1 trial · 1 indication

Phase 2 1
NCT02217566Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol TherapyProstatic Neoplasms
COMPLETED46 Analytics
PHASE2COMPLETED
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Prostatic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Prostate-specific Antigen (PSA) Progression
Up to 2 years

Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (\>=) 25 percent (%) and \>=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is \>=25% and \>=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline).

Secondary Endpoints

Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response
Week 12 to any time up to 2 years
Overall Survival
Up to 4 years
Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score
Up to 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Abiraterone AcetateEXPERIMENTALParticipants will receive abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

Interventions

NameTypeDescription
Abiraterone acetateDRUGParticipants will receive abiraterone acetate 1000 mg (4\*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
PrednisoneDRUGParticipants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Androgen deprivation therapy (ADT)DRUGParticipants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer. Participants should demonstrate evidence of progressi...

Countries:Brazil
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Frequently asked questions about Androgen deprivation therapy

What is Androgen deprivation therapy used for?

Androgen deprivation therapy is used for prostatic neoplasms, specifically in the treatment of prostate cancer. It is being studied in the context of metastatic castration-resistant prostate cancer (mCRPC) in patients who have previously received diethylstilbestrol therapy. The therapy is under investigation as a treatment option for this patient population.

Who makes Androgen deprivation therapy?

Androgen deprivation therapy is being developed by Johnson & Johnson, a company traded under the ticker JNJ. The therapy is currently in Phase 2 clinical development for the treatment of prostate cancer.

What phase is Androgen deprivation therapy in?

Androgen deprivation therapy is in Phase 2 clinical development. It is an investigational therapy and has not yet been approved by regulatory authorities. The therapy is being studied in a clinical trial for patients with metastatic castration-resistant prostate cancer.

What clinical trials is Androgen deprivation therapy in?

Androgen deprivation therapy is associated with one completed clinical trial, NCT02217566. This Phase 2 study evaluated the therapy in participants with metastatic castration-resistant prostate cancer who were chemo-naive and had received prior diethylstilbestrol therapy. The trial was conducted in Brazil and enrolled 46 male participants aged 18 years and older.

Is Androgen deprivation therapy the same as Androgen Deprivation Therapy (ADT)?

Yes, Androgen deprivation therapy is also known as Androgen Deprivation Therapy (ADT) and Androgen-deprivation Therapy (ADT). These names refer to the same therapeutic approach being developed by Johnson & Johnson for the treatment of prostate cancer.