New radioactive drug aims to slow advanced prostate cancer in major trial
NCT ID NCT07611110
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This study tests a new drug called AZD2265, which delivers radiation directly to prostate cancer cells. It is for people with a type of advanced prostate cancer that no longer responds to hormone therapy. The trial compares the new drug to standard treatments to see if it can slow cancer growth and help people live longer.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 670 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2030
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: * ≥ 18 years of age. * Diagnosis of adenocarcinoma of prostate. * Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone. * Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan. * Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate. * Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC. * Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.). * Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL). * ECOG performance status of 0 to 2. * Adequate organ and bone marrow function as described in study protocol. * Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention. * Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners. Exclusion Criteria: * Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted). * Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3. * Receipt of \> 6 cycles of PSMA-directed β-emitting therapeutic RC. * History of another primary malignancy, with exceptions. * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions. * Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention. * Clinically significant ECG abnormalities, with exceptions.
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Get notified about this study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
129 sites in 20 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGDothan, Alabama, 36303, United States
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NOT_YET_RECRUITINGPhoenix, Arizona, 85004, United States
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NOT_YET_RECRUITINGDuarte, California, 91010, United States
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NOT_YET_RECRUITINGIrvine, California, 92618, United States
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RECRUITINGNewport Beach, California, 92660, United States
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NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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RECRUITINGMiami, Florida, 33165, United States
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NOT_YET_RECRUITINGO'Fallon, Illinois, 62269, United States
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RECRUITINGMetairie, Louisiana, 70006, United States
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WITHDRAWNDetroit, Michigan, 48201, United States
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NOT_YET_RECRUITINGGrand Rapids, Michigan, 49503, United States
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NOT_YET_RECRUITINGSt Louis, Missouri, 63104, United States
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RECRUITINGOmaha, Nebraska, 68130, United States
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NOT_YET_RECRUITINGAlbuquerque, New Mexico, 87109, United States
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NOT_YET_RECRUITINGNew Hyde Park, New York, 11042, United States
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NOT_YET_RECRUITINGNew York, New York, 10065, United States
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NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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NOT_YET_RECRUITINGDayton, Ohio, 45415, United States
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NOT_YET_RECRUITINGPortland, Oregon, 97239, United States
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NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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NOT_YET_RECRUITINGMyrtle Beach, South Carolina, 29572, United States
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NOT_YET_RECRUITINGNashville, Tennessee, 37203, United States
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RECRUITINGHouston, Texas, 77042, United States
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NOT_YET_RECRUITINGSalt Lake City, Utah, 84106, United States
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NOT_YET_RECRUITINGTacoma, Washington, 98405, United States
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NOT_YET_RECRUITINGDarlinghurst, 2010, Australia
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NOT_YET_RECRUITINGKurralta Park, 5037, Australia
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NOT_YET_RECRUITINGMelbourne, 3000, Australia
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NOT_YET_RECRUITINGMurdoch, WA6150, Australia
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NOT_YET_RECRUITINGLinz, 4020, Austria
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NOT_YET_RECRUITINGSalzburg, 5020, Austria
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NOT_YET_RECRUITINGSão Paulo, 01308-050, Brazil
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NOT_YET_RECRUITINGSão Paulo, 05652-900, Brazil
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NOT_YET_RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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NOT_YET_RECRUITINGHalifax, Nova Scotia, B3H 1V7, Canada
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NOT_YET_RECRUITINGHamilton, Ontario, L8V 1C3, Canada
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NOT_YET_RECRUITINGToronto, Ontario, M4N 3M5, Canada
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NOT_YET_RECRUITINGToronto, Ontario, M5G 2M9, Canada
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NOT_YET_RECRUITINGMontreal, Quebec, H3A 1A1, Canada
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RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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NOT_YET_RECRUITINGBeijing, 100034, China
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NOT_YET_RECRUITINGBeijing, 100142, China
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NOT_YET_RECRUITINGChengdu, 610041, China
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NOT_YET_RECRUITINGChongqing, 400030, China
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NOT_YET_RECRUITINGFuzhou, 350005, China
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NOT_YET_RECRUITINGGuangzhou, 510060, China
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NOT_YET_RECRUITINGGuangzhou, 510120, China
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NOT_YET_RECRUITINGGuangzhou, 510630, China
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NOT_YET_RECRUITINGHangzhou, 310003, China
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NOT_YET_RECRUITINGHangzhou, 310014, China
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NOT_YET_RECRUITINGHangzhou, 310022, China
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NOT_YET_RECRUITINGJinan, 250117, China
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NOT_YET_RECRUITINGNanjing, 210006, China
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SUSPENDEDNanjing, 210029, China
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NOT_YET_RECRUITINGShanghai, 200025, China
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NOT_YET_RECRUITINGShanghai, 200032, China
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NOT_YET_RECRUITINGShenyang, 110001, China
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NOT_YET_RECRUITINGWuhan, 430022, China
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NOT_YET_RECRUITINGWuhan, 430030, China
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NOT_YET_RECRUITINGXi'an, 710061, China
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NOT_YET_RECRUITINGKuopio, 70210, Finland
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NOT_YET_RECRUITINGVillejuif, 94800, France
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NOT_YET_RECRUITINGAugsburg, 86156, Germany
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NOT_YET_RECRUITINGBerlin, 13353, Germany
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NOT_YET_RECRUITINGBonn, 53127, Germany
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NOT_YET_RECRUITINGCologne, 50937, Germany
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NOT_YET_RECRUITINGDresden, 01307, Germany
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NOT_YET_RECRUITINGEssen, 45122, Germany
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NOT_YET_RECRUITINGJena, 07747, Germany
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WITHDRAWNKarlsruhe, 76133, Germany
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NOT_YET_RECRUITINGMünchen, 81675, Germany
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NOT_YET_RECRUITINGMünster, 48149, Germany
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WITHDRAWNNuremberg, 90419, Germany
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NOT_YET_RECRUITINGRostock, 18057, Germany
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NOT_YET_RECRUITINGStuttgart, 70174, Germany
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NOT_YET_RECRUITINGTübingen, 72076, Germany
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NOT_YET_RECRUITINGWürzburg, 97080, Germany
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NOT_YET_RECRUITINGBangalore, 560017, India
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NOT_YET_RECRUITINGGurgaon, 122001, India
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NOT_YET_RECRUITINGGurgaon, 122002, India
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NOT_YET_RECRUITINGNavi Mumbai, 410210, India
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NOT_YET_RECRUITINGHaifa, 3109601, Israel
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NOT_YET_RECRUITINGJerusalem, 00000, Israel
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NOT_YET_RECRUITINGPetah Tikva, 4941492, Israel
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NOT_YET_RECRUITINGRamat Gan, 52621, Israel
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NOT_YET_RECRUITINGTel Aviv, 64239, Israel
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NOT_YET_RECRUITINGChiba, 260-8717, Japan
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NOT_YET_RECRUITINGChūōku, 104-0045, Japan
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RECRUITINGFukuoka, 812-8582, Japan
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NOT_YET_RECRUITINGHamamatsu, 431-3192, Japan
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NOT_YET_RECRUITINGKamakura-shi, 247-8533, Japan
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RECRUITINGKanazawa, 920-8641, Japan
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NOT_YET_RECRUITINGKashiwa, 227-8577, Japan
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NOT_YET_RECRUITINGKobe, 650-0047, Japan
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NOT_YET_RECRUITINGKyoto, 606-8507, Japan
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RECRUITINGSapporo, 060-8638, Japan
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NOT_YET_RECRUITINGSuita-shi, 565-0871, Japan
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NOT_YET_RECRUITINGYokohama, 236-0004, Japan
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NOT_YET_RECRUITINGGdansk, 80-214, Poland
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NOT_YET_RECRUITINGKrakow, 31-501, Poland
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NOT_YET_RECRUITINGWarsaw, 02-781, Poland
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NOT_YET_RECRUITINGGoyang-si, 10408, South Korea
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NOT_YET_RECRUITINGSeoul, 03080, South Korea
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NOT_YET_RECRUITINGSeoul, 06591, South Korea
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NOT_YET_RECRUITINGSeoul, 3722, South Korea
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NOT_YET_RECRUITINGSeoul, 5505, South Korea
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NOT_YET_RECRUITINGSeoul, 6351, South Korea
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NOT_YET_RECRUITINGBarcelona, 08025, Spain
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NOT_YET_RECRUITINGBarcelona, 8035, Spain
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NOT_YET_RECRUITINGL'Hospitalet de Llobregat, 08908, Spain
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NOT_YET_RECRUITINGMadrid, 28041, Spain
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NOT_YET_RECRUITINGMajadahonda, 28222, Spain
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NOT_YET_RECRUITINGMálaga, 29009, Spain
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Research Site
NOT_YET_RECRUITINGSantiago de Compostela, 15706, Spain
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NOT_YET_RECRUITINGStockholm, 17176, Sweden
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NOT_YET_RECRUITINGUmeå, 901 85, Sweden
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NOT_YET_RECRUITINGKaohsiung City, 833401, Taiwan
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NOT_YET_RECRUITINGTaipei, 10002, Taiwan
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Research Site
NOT_YET_RECRUITINGTaipei, 11217, Taiwan
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Research Site
NOT_YET_RECRUITINGTaipei, 11259, Taiwan
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NOT_YET_RECRUITINGTaoyuan, 333, Taiwan
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NOT_YET_RECRUITINGBangkok, 10210, Thailand
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Research Site
NOT_YET_RECRUITINGBangkok, 10700, Thailand
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NOT_YET_RECRUITINGAnkara, 06530, Turkey (Türkiye)
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Research Site
NOT_YET_RECRUITINGAnkara, 06620, Turkey (Türkiye)
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NOT_YET_RECRUITINGIstanbul, 34098, Turkey (Türkiye)
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NOT_YET_RECRUITINGIstanbul, 34752, Turkey (Türkiye)
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NOT_YET_RECRUITINGLondon, EC1A 7BE, United Kingdom
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NOT_YET_RECRUITINGMiddlesbrough, TS4 3BW, United Kingdom
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Research Site
NOT_YET_RECRUITINGSouthampton, SO16 6YD, United Kingdom
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Research Site
NOT_YET_RECRUITINGTruro, TR1 3LJ, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- 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?