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Triple attack on prostate cancer: drug, surgery, and radiation aim to stop spread

NCT ID NCT07490210

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding surgery and targeted radiation to a new hormone-blocking drug (rezvilutamide) can help men whose prostate cancer has spread to a few spots (oligometastatic). 300 men will be split into three groups: one gets the drug alone, one gets drug plus surgery, and one gets drug plus surgery plus radiation. The goal is to see which approach best delays cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rezvilutamide (a hormone-blocking drug) plus androgen deprivation therapy (ADT)
What this could lead to
If successful, this combination approach could offer a way to delay cancer progression and improve survival for men with prostate cancer that has spread to a few spots.
What could go wrong
This is an early Phase 2 trial, so results are not yet proven. The added treatments (surgery and radiation) carry risks like side effects from surgery or radiation, and the drug may cause fatigue, hot flashes, or other hormone-related issues.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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: 1. Voluntary participation with signed informed consent and understanding of study procedures. 2. Age ≥18 years. 3. Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology. 4. Metastatic hormone-sensitive prostate cancer (mHSPC) with oligometastatic disease defined as: a) ≤10 metastatic lesions combined (bone lesions on Tc-99m bone scan plus extra-pelvic lymph nodes on CT/MRI); and b) No visceral metastases on CT/MRI. 5. Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist/antagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment. 6. Adequate organ function (without transfusion or hematopoietic growth factor support within 2 weeks prior to screening labs): * Absolute neutrophil count (ANC) ≥1.5×10⁹/L * Platelet count (PLT) ≥100×10⁹/L * Hemoglobin (Hb) ≥90 g/L * Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance \>50 mL/min * Total bilirubin (BIL) ≤1.5×ULN * AST/SGOT or ALT/SGPT ≤2.5×ULN * International normalized ratio (INR) ≤1.5, PT and APTT ≤1.5×ULN * Left ventricular ejection fraction (LVEF) ≥50% 7. Male patients with female partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose, and must not donate sperm during this period. 8. Ability to comply with the study protocol as judged by the investigator. 9. Ability to adhere to scheduled visits, treatment plans, and laboratory assessments. Exclusion Criteria: 1. Prior radical prostatectomy, pelvic radiotherapy, prostatic ablation, or any systemic anti-prostate cancer therapy (including novel hormonal therapy, chemotherapy, radionuclide therapy, cancer vaccines, or immune checkpoint inhibitors), except ADT initiated ≤4 weeks prior to randomization that meets inclusion criteria. 2. Prior radiotherapy to prostate cancer metastases. 3. Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases. 4. Severe contraindications to surgery or radiotherapy, including major cardiovascular disease (e.g., NYHA Class III-IV heart failure, recent myocardial infarction), pulmonary insufficiency unable to tolerate anesthesia, severe bleeding tendency, or bone marrow suppression. 5. Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for \>5 years. 6. Active infections, including active hepatitis B (HBV DNA \>2×10³ IU/mL), hepatitis C RNA positive with hepatic impairment, HIV infection, or inadequately treated syphilis. 7. Uncontrolled major cardiovascular disease within 6 months prior to screening, including: a) unstable angina or recent myocardial infarction (within 6 months); b) clinically significant arrhythmias (e.g., sustained ventricular tachycardia); c) heart failure (NYHA Class ≥III). 8. Severe hepatic or renal dysfunction or other laboratory abnormalities not meeting the organ function requirements specified in Inclusion Criterion #6. 9. Known hypersensitivity or history of severe adverse reactions to study medications (novel hormonal agents), anesthetics, or contrast agents used in the study. 10. Any medical, psychological, or social factors that may affect patient compliance or interfere with study outcome assessment, including psychiatric disorders, substance abuse, or other conditions deemed unsuitable by the investigator. 11. Concurrent participation in another interventional clinical study, or use of any investigational drug or medical device within 4 weeks prior to randomization. 12. Any other condition that the investigator considers unsuitable for study participation. \-

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

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