New hope for chinese men with advanced prostate cancer?
NCT ID NCT03523442
First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-stage study tests the drug apalutamide in 19 Chinese men whose prostate cancer has spread and no longer responds to hormone therapy. Researchers want to see how the drug behaves in the body and if it is safe. They will also check if it lowers PSA levels, a marker of cancer activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apalutamide
- What this could lead to
- If successful, this could confirm that apalutamide is safe and works similarly in Chinese patients, supporting its use for controlling advanced prostate cancer.
- What could go wrong
- This is a very early, small study with only 19 participants. It focuses on safety and drug levels, not on proving the drug works. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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19 people
The number who actually took part.
- Started
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Aug 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2 * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria * Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL) * Prior hormonal interventions (including 1st generation antiandrogens \[flutamide, bicalutamide, nilutamide\], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug Exclusion Criteria: * Known brain metastases * Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. * Prior treatment with second-generation anti-androgens (example \[eg\], enzalutamide) * Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug * Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Cancer Hospital of Peking University
Beijing, 100142, China
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Fudan Cancer Hospital
Shanghai, 200032, China
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Jiangsu Cancer Hospital
Nanjing, 210000, China
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Peking University Third Hospital
Beijing, 100083, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer