Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Radioactive drug shows promise for tough prostate cancer

NCT ID NCT05670106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

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.