New hope for chinese men with tough prostate cancer: targeted drug takes on standard care
NCT ID NCT05457257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares the targeted drug olaparib to two standard hormone therapies (enzalutamide or abiraterone) in Chinese men with advanced prostate cancer that has stopped responding to hormone treatment and who have BRCA1/2 gene mutations. The goal is to see if olaparib can delay cancer growth better than the usual options. About 43 men will participate, and the study tracks how long their cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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43 people
The number who actually took part.
- Started
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Jul 2022
- 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: 1. Histologically confirmed diagnosis of prostate cancer. 2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC). 3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC . 4. Ongoing therapy with LHRH analog or bilateral orchiectomy. 5. Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy). 6. Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue. 7. Normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. Exclusion criteria: 1. Any previous treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor, including olaparib. 2. Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization. 3. History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence. 4. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
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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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Research Site
Beijing, 100050, China
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Research Site
Bengbu, 233004, China
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Research Site
Changsha, 410008, China
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Research Site
Changsha, 410013, China
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Research Site
Chengdu, 610000, China
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Research Site
Chongqing, 408099, China
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Research Site
Fuzhou, 350005, China
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Research Site
Guangzhou, 510060, China
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Research Site
Guangzhou, 510180, China
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Research Site
Hangzhou, 310003, China
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Research Site
Hangzhou, 310009, China
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Research Site
Hangzhou, 310014, China
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Research Site
Hefei, 230601, China
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Research Site
Jiaxing, 314001, China
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Research Site
Jinan, 250012, China
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Research Site
Jinan, 250021, China
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Research Site
Jining, 272029, China
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Research Site
Kunming, 650101, China
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Research Site
Lanzhou, 730030, China
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Research Site
Linyi, 276000, China
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Research Site
Nanchang, 330006, China
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Research Site
Nantong, 226361, China
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Research Site
Ningbo, 315010, China
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Research Site
Shanghai, 200002, China
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Research Site
Shanghai, 200032, China
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Research Site
Shenyang, 110004, China
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Research Site
Suzhou, 215004, China
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Research Site
Taiyuan, 030000, China
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Research Site
Tianjin, 300060, China
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Research Site
Wanzhou, 404000, China
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Research Site
Wuhan, 430022, China
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Research Site
Wuxi, 214002, China
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Research Site
Wuxi, 214023, China
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Research Site
Xi'an, 710077, China
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Research Site
Zhengzhou, 450052, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?