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New hope for recurrent prostate cancer: drug combo aims to control PSA without hormone therapy

NCT ID NCT06096870

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 10 times

Summary

This study tests whether adding an injected drug (PDS01ADC) to a daily pill (enzalutamide) can better control PSA levels in men whose prostate cancer has returned after initial treatment. About 65 participants will receive either enzalutamide alone or both drugs for 3 months, with possible extra treatment. The goal is to delay cancer progression without using standard testosterone-lowering therapy.

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 65 people

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

Started

Apr 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 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: * Participant must provide documentation of histologic or cytological confirmation of prostate cancer or tumor sample for diagnosis confirmation. Note: in the absence of pathology or documentation, participant must have a rising PSA, PSMA+ disease, and his history consistent with prostate cancer as documented by the investigator. * History of primary treatment for prostate cancer (either surgery or radiation). * Prostate-specific antigen (PSA) doubling time within less than 12 months. * Testosterone \>100 ng/dL. * Age \>=18 years. * Evidence of prostate cancer on PSMA PET/CT scan. * Eastern Cooperative Oncology Group (ECOG) performance status \<2. * Men must agree to use an effective method of contraception (barrier or surgical sterilization) after study entry and for 3 months after completion of enzalutamide or PDS01ADC therapy whatever comes later. * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count (ANC) \>=1,500/microliter, without granulocyte colony-stimulating factor (G-CSF) support * Platelets \>=100,000/microliter * Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT) \<=2.5 x institutional upper limit of normal (ULN) * Hemoglobin (Hgb) \>= 10 g/dL (packed red blood cell (pRBC) transfusions are not allowed to achieve acceptable Hgb) * Total bilirubin \<= 1.5 x ULN, OR \<= 3.0 ULN in participants with Gilbert s syndrome * Serum albumin \>= 2.8 g/dL * Creatinine \< 1.5 X institution ULN OR --Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl) \> 45 mL/min/1.73 m\^2 for participant with creatinine levels \> 1.5 x institutional ULN * Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable at screening. Hepatitis C virus (HCV)-infected participants can be enrolled if the HCV RNA level is undetectable at screening. Human immunodeficiency virus (HIV)-positive participants can be enrolled if HIV DNA is undetectable. * Participants must be able to swallow tablets/capsules. * Participants must be able to understand and willing to sign a written informed consent document. EXCLUSION CRITERIA: * Evidence of soft tissue disease on CT scan (or magnetic resonance imaging (MRI) if assessment cannot be done by CT scan) per RECIST 1.1 criteria (lymph nodes up to 2.0 cm in the shortest dimension are allowed). * Evidence of bone lesions on Tc99 bone scan. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or imaging agents used in the study. * Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted). * History of seizures within the last 10 years. * Therapy with strong inhibitors or inducers of CYP2C8 or CYP3A4 within 5 half-lives prior to the study treatment initiation. Standard clinical resources (e.g., Lexidrug) should be consulted to determine the classification of CYP inhibitors and inducers. * Participants with prior malignancy active within 3 years prior to study treatment initiation except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast. * Uncontrolled intercurrent illness that would limit compliance with study requirements.

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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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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