Testing enzalutamide and PDS01ADC for recurrent prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of enzalutamide, both alone and in combination with PDS01ADC, in treating patients with recurrent prostate cancer that is PET positive. Participants will undergo screening, including physical exams, blood tests, and imaging scans, to assess their condition. The treatment will be administered in 4-week cycles, with enzalutamide taken orally daily and PDS01ADC injected monthly. The study seeks to determine if this combination can improve patient outcomes compared to existing therapies.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Melissa L Abel, M.D. — National Cancer Institute (NCI)
• Study coordinator: Amy R Hankin, P.A.-C
• Email: amy.hankin@nih.gov
• Phone: (240) 858-3149

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.