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

NCT06096870 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10001556001556-C
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed. Objective: To test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment. Eligibility: People aged 18 years and older with prostate cancer that returned after treatment. Design: Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample. Participants will be treated in 4-week cycles. Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home. PDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs. All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated. All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once. Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated. ...

Conditions

Prostate Cancer; Recurrent Prostate Cancer; PET Positive

Keywords

Combination Therapy; Recurrent Prostate Cancer; PET Positive; Enzalutamide; PDS01ADC

Outcome Measures

Primary Outcomes (1)

• 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

  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

  5 years

Secondary Outcomes (4)

• PET changes after enzalutamide with and without PDS01ADC treatment

  1 year

• Safety of study treatment

  until 30 days after last dose of study drug

• Evaluate immune response

  1 year

• PSA detection

  1 year

Study Arms (2)

Arm 1

EXPERIMENTAL

Enzalutamide

Drug: Enzalutamide

Arm 2

EXPERIMENTAL

Enzalutamide+PDS01ADC

Drug: Enzalutamide; Drug: PDS01ADC

Interventions

Enzalutamide DRUG

Enzalutamide at 160 mg once daily on every day of the cycle (every 28 days)

Arm 1; Arm 2

PDS01ADC DRUG

PDS01ADC at 12.0 microgram/kg by subcutaneous injection (every 28 days)

Arm 2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (https://druginteractions.medicine.iu.edu/MainTable.aspx) within 5 half-lives prior to the study treatment initiation.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Melissa L Abel, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy R Hankin, P.A.-C

CONTACT

(240) 858-3149; amy.hankin@nih.gov

Melissa L Abel, M.D.

CONTACT

(240) 447-5353; melissa.abel@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 24, 2023
• Study Start: April 22, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)