Radioactive drug shows promise for tough prostate cancer
NCT ID NCT05670106
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tested a radioactive drug called 177Lu-PSMA-617 in 62 Chinese men with advanced prostate cancer that had spread and stopped responding to hormone therapy and chemotherapy. The drug targets a protein on cancer cells and delivers radiation directly to them. Researchers measured how well it shrank tumors and how safe it was, aiming to support approval in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-PSMA-617 (a radioactive drug that targets prostate cancer cells)
- What this could lead to
- If successful, this could provide a new treatment option for Chinese men with advanced prostate cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a phase 2 study with only 62 participants, so results may not apply to all patients. The drug involves radiation, which can cause side effects like dry mouth, fatigue, and 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
62 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Apr 2026
- Lead sponsor
-
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
-
18 to 100 years
- Sex
-
Male participants only
- Healthy volunteers
-
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: * Written informed consent must be obtained before any assessment is performed. * Participants must be Chinese male adults \>= 18 years of age. * Participants must have histological, pathological, and/or cytological confirmation of prostate cancer. * Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules. * Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L). * Participants must have received at least one ARPI (such as enzalutamide and/orabiraterone). * Participants must have been previously treated with at least 1, but no more than 2 previous taxane regimens. * A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.) * Documented progressive mCRPC, based on at least 1 of the following criteria: * Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng/ml * Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016) * Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016) * Participants must have \>= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =\< 21 days prior to enrollment via central reading. * In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading * Participants must have adequate organ function: * Bone marrow reserve: * White blood cell (WBC) count \>= 2.5 × 109/L OR absolute neutrophil count (ANC) \>= 1.5 × 109/L * Platelets \>=100 × 109/L * Hemoglobin \>= 9 g/dL * Hepatic: * Total bilirubin =\< 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =\< 3 × ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\< 3.0 × ULN OR =\< 5.0 × ULN for participants with liver metastases * Renal: * eGFR \>= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation * Albumin \>3.0 g/dL. Exclusion Criteria: * Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. * Previous PSMA-targeted radioligand therapy. * Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\], APRI is not included) within 28 days prior to day of enrollment. * Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors \[PARPi\]) within 28 days prior to day of enrollment. * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. * Transfusion for the sole purpose of making a subject eligible for study inclusion. * Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. * Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. * Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. * Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Novartis Investigative Site
Guangzhou, Guangdong, 510120, China
-
Novartis Investigative Site
Zhengzhou, Henan, 450003, China
-
Novartis Investigative Site
Zhengzhou, Henan, 450008, China
-
Novartis Investigative Site
Wuhan, Hubei, 430022, China
-
Novartis Investigative Site
Nanjing, Jiangsu, 210006, China
-
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
-
Novartis Investigative Site
Xian, Shanxi, 710032, China
-
Novartis Investigative Site
Xian, Shanxi, 710061, China
-
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
-
Novartis Investigative Site
Beijing, 100034, China
-
Novartis Investigative Site
Beijing, 100036, China
-
Novartis Investigative Site
Beijing, 100730, China
-
Novartis Investigative Site
Guangzhou, 510060, China
-
Novartis Investigative Site
Shanghai, 200025, China
-
Novartis Investigative Site
Shanghai, 200032, China
-
Novartis Investigative Site
Shanghai, 200080, China
-
Novartis Investigative Site
Tianjin, 300300, 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?