RECRUITING

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

Conditions

Prostate Cancer Recurrent Prostate Cancer PET Positive Combination Therapy Enzalutamide PDS01ADC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06096870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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.	* 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.

Inclusion Criteria

Exclusion 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
* 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.

* 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.

Contacts and Locations

Study Contact

Amy R Hankin, P.A.-C

CONTACT

(240) 858-3149

amy.hankin@nih.gov

Ravi A Madan, M.D.

CONTACT

(301) 480-7168

rm480i@nih.gov

Principal Investigator

Ravi A Madan, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Ravi A Madan, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Combination Therapy
Recurrent Prostate Cancer
PET Positive
Enzalutamide
PDS01ADC

Additional Relevant MeSH Terms

Prostate Cancer
Recurrent Prostate Cancer
PET Positive