Metastatic Castration-Resistant Prostate CancerEarly Phase 1SRT-017-001NCT07798778
Clinical Evaluation of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study testing SRT-017 in people with Metastatic Castration-Resistant Prostate Cancer, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- SRT-017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Chunjing Yu, Doctor, +86 0510-68088861, ycj_wxd1978@163.com
About this study
Official title: To Evaluate the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Antitumor Efficacy of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.
- Being tested
- SRT-017
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, PSMA, Radioligand Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRT-017Drug
Investigational PSMA-targeted radiopharmaceutical, administered intravenously for male patients with metastatic castration-resistant prostate cancer (mCRPC). Dosing and administration will follow the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| SRT-017-001 Radioligand Therapy Group | Experimental | Male patients with metastatic castration-resistant prostate cancer (mCRPC) will receive investigational PSMA-targeted radiopharmaceutical SRT-017-001 by intravenous injection according to the study protocol. Receives: Drug: SRT-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline)
Proportion of participants achieving confirmed ≥50% PSA reduction from baseline according to PCWG3 criteria. Confirmation requires a second PSA measurement at least 4 weeks later sustaining ≥50% decline.
Measured: From first study drug administration up to 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start30 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm open-label study. All enrolled participants will receive SRT-017 radioligand therapy. No control group.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
- Investigators
- chunjing yu, MD, Study chair, The Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798778
- Sponsor's protocol ID
- SRT-017-001
- Other IDs
- LS2026172
- Acronym
- SRT-017-001
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Antitumor Efficacy of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT07798778
- Acronym / sponsor ID
- SRT-017-001 / SRT-017-001
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, PSMA, Radioligand Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm open-label study. All enrolled participants will receive SRT-017 radioligand therapy. No control group.
| Arm | Type | Receives |
|---|---|---|
| SRT-017-001 Radioligand Therapy Group | Experimental | Drug: SRT-017Male patients with metastatic castration-resistant prostate cancer (mCRPC) will receive investigational PSMA-targeted radiopharmaceutical SRT-017-001 by intravenous injection according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRT-017Investigational PSMA-targeted radiopharmaceutical, administered intravenously for male patients with metastatic castration-resistant prostate cancer (mCRPC). Dosing and administration will follow the study protocol. | Drug | SRT-017-001 Radioligand Therapy Group |
Primary outcome
Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline)
Time frame: From first study drug administration up to 12 weeks post-treatment
Proportion of participants achieving confirmed ≥50% PSA reduction from baseline according to PCWG3 criteria. Confirmation requires a second PSA measurement at least 4 weeks later sustaining ≥50% decline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
chunjing yu, MD study chair
The Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SRT-017 in people with Metastatic Castration-Resistant Prostate Cancer, run by Affiliated Hospital of Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chunjing yu, MD (+86 15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline) (time frame: From first study drug administration up to 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.