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Enzalutamide and PDS01ADC for PET Positive Recurrent Prostate Cancer

This study is looking for men aged 18 to 120 with prostate cancer that has returned after treatment and shows up on a PET scan. It's testing if combining two drugs, enzalutamide and PDS01ADC, works better than enzalutamide alone. Enzalutamide is a drug that helps control prostate-specific antigen (PSA) (a marker for prostate cancer). PDS01ADC is an immunocytokine that targets tumor cells. The main goal is to see if the combination keeps PSA levels suppressed for a longer time, measured over 5 years. The study aims to enroll 65 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 65 participants.
What's involved
You will be screened with a physical exam, blood tests, 24-hour urine collection, and imaging scans. You will then receive treatment in 4-week cycles.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 5 years, suggesting a follow-up period of at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06096870

Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~65 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:EnzalutamidePDS01ADC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine if the combination of enzalutamide and PDS01ADC is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone
Measured over 5 years

Conditions

Prostate Cancer
Recurrent Prostate Cancer
PET Positive

Explore related trials

Prostate CarcinomaFOLH1 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Melissa L Abel, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Amy R Hankin, P.A.-C
[email protected]
(240) 858-3149
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Determine if the combination of enzalutamide and PDS01ADC is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone5 years

    Kaplan-Meier curves and a one-tailed log-rank test. The median time to loss of PSA control on each arm will be reported along with a 95% confidence interval; in addition, based on the result from the prior trial, the probability of PSA control at 224 days (approximately 7 months) will also be reported on both arms, along with 95% confidence intervals