Health TrialsbyHealthPanel

Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer

ConditionAdvanced Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age19+
SponsorDongkook Pharmaceutical Co., Ltd.

About this trial

A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male aged 19 or older

Histologically or cytologically-confirmed prostate cancer

Serum testosterone level >150 ng/dL

ECOG PS grade ≤ 2

Disqualifiers

History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection

History of hormone therapy

History of 5α-reductase inhibitor

History of radical radiation therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • DKF-MA102

    Drug

    Administered twice at 12-week intervals

Treatment groups

154 Participants
are divided into 1 treatment group
Group A: DKF-MA102Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants

Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4

Time frame
Week 4
2

Percentage of participants

Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24

Time frame
Week 24

Secondary outcomes

1

Serum luteinizing hormone(LH) levels

Changes in serum luteinizing hormone(LH) levels from baseline to Weeks 4, 12 and 24

Time frame
Week 24
2

Serum prostate specific antigens(PSA)

Changes in serum prostate specific antigens(PSA) from baseline to Weeks 4, 12 and 24

Time frame
Week 24
3

Percentage of participants

Percentage of participants with testosterone suppression(≤ 20ng/dL) from Week 4 to Week 24

Time frame
Week 24
4

Quality of life(FACT-P)

Comparative evaluation of quality of life(FACT-P) of subjects from baseline to Weeks 4, 12 and 24

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongkook Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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