Can a smart radiation drug hunt down prostate cancer cells?
NCT ID NCT07798778
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This early-phase trial tests an investigational drug called SRT-017 in men with a type of advanced prostate cancer that has stopped responding to hormone therapy. The drug is designed to seek out and deliver radiation directly to cancer cells that carry a marker called PSMA. Researchers are checking whether the treatment is safe, how it moves through the body, and whether it can shrink tumors or lower PSA levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SRT-017, an investigational targeted radiation therapy that seeks out PSMA on prostate cancer cells
- What this could lead to
- If it works, SRT-017 could offer a new way to shrink tumors and lower PSA levels in men with advanced prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is a very early, small trial focused on safety, so the drug may not prove effective. Radiation therapy can also cause side effects like fatigue, dry mouth, or low blood counts.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Male participants aged 18 years or older. * Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is defined as disease progression under continuous androgen-deprivation therapy (ADT) or after prior bilateral orchiectomy, with serum testosterone maintained at castrate level (\<50 ng/dL or \<1.7 nmol/L), meeting at least one of the Prostate Cancer Working Group 3 (PCWG3) progression criteria: PSA progression (PSA ≥1 ng/mL, ≥25 % increase compared with PSA nadir with an absolute rise ≥2 ng/mL confirmed by two consecutive measurements at least 1 week apart); or radiographic progression (≥2 new bone metastatic lesions on bone scan, or soft-tissue disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)). * Disease progression after treatment with at least one novel androgen-axis drug (NAAD), including abiraterone, enzalutamide, apalutamide, or darolutamide. * Prior chemotherapy, or participants who are ineligible for chemotherapy or decline chemotherapy. * PSMA-positive lesions confirmed by PSMA-PET/CT imaging; PSMA-positive is defined as tumor lesion uptake higher than liver background uptake. * At least one measurable lesion by RECIST 1.1 criteria OR at least one bone metastasis lesion by PCWG3 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. * Estimated life expectancy of at least 6 months. * No transfusion of blood products, hematopoietic growth factors, or albumin within 14 days before baseline laboratory tests, and adequate organ function as follows: hematologic: absolute neutrophil count ≥ 1.5 × 10⁹/L, white blood cell count ≥ 3.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL; hepatic: albumin ≥ 30 g/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤ 3 × ULN (without liver metastases) or ALT/AST ≤ 5 × ULN (with liver metastases); renal: serum creatinine ≤ 1.5 × ULN; coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 2 × ULN. * Willing to comply with radiation-protection instructions and scheduled study follow-up procedures. * Able to understand study procedures and voluntarily provide written informed consent, and willing to comply with all study-related assessments and follow-up requirements. Exclusion Criteria: * Participants unable to tolerate required imaging examinations. * Received systemic anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy; endocrine therapy is exempt), investigational medicinal products, or investigational medical devices within 4 weeks prior to first study drug administration. * Received prior radiopharmaceutical therapy (such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177) within 6 months before first dose; or received external-beam radiation therapy (EBRT) within 2 months before first dose. * Persistent Grade 4 myelosuppression from prior anti-cancer therapy within 2 weeks before screening, or Grade 3 myelosuppression with recovery duration longer than 6 weeks. * Plan to receive cytotoxic chemotherapy, anti-tumor immunotherapy, radioligand therapy, or other similar anti-cancer treatments during study participation. * Known brain metastases identified at screening. * History of other malignant neoplasms within the past 5 years (curative-treated localized tumors such as basal-cell or squamous-cell skin cancer are permitted). * Symptomatic or impending spinal cord compression. * Prior external-beam radiation therapy covering more than 25 % of bone-marrow-containing skeletal regions. * Significant uncontrolled cardiovascular disease at screening: QTcF \> 470 ms or known long QT syndrome; myocardial infarction, angina pectoris, or coronary artery bypass graft (CABG) within 6 months before screening and judged unsuitable for study entry by investigator. * Uncontrolled bladder-outlet obstruction, urinary incontinence, claustrophobia, or radiophobia at screening. * Positive screening serology for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody. * Hepatitis B surface antigen (HBsAg) positive with active hepatitis B virus (HBV) replication as assessed by HBV-DNA testing and investigator judgment. * Known hypersensitivity to proteins/peptides, drug excipients, or structurally related compounds. * Documented history of drug or alcohol abuse or chronic substance dependence within 1 year prior to screening. * Unwilling to practice effective contraception during study participation and for 6 months after last study drug administration. * Severe active ongoing infection at the time of first planned study drug administration. * Any other medical condition which, in the investigator's judgment, may compromise participant safety, interfere with study result interpretation, or confer unacceptable participant risk.
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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
1 site. 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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Affiliated Hospital of Jiangnan University
RECRUITINGWuxi, Jiangsu, 214000, China
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Other studies related to the condition(s) this trial covers.
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- Can a new pill outsmart resistant prostate cancer?
- Can a radioactive 'Smart Bomb' outsmart advanced prostate cancer?