OncoMatch/Clinical Trials/NCT06096870
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
Is NCT06096870 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Enzalutamide and PDS01ADC for prostate cancer.
Treatment: Enzalutamide · PDS01ADC — 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. ...
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: KLK3 doubling time < 12 months
Prostate-specific antigen (PSA) doubling time within less than 12 months
Required: AR testosterone >100 ng/dl
Testosterone >100 ng/dL
Required: PSMA (FOLH1) psma positive by pet/ct
Evidence of prostate cancer on PSMA PET/CT scan
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: definitive local therapy — primary treatment for prostate cancer (either surgery or radiation)
History of primary treatment for prostate cancer (either surgery or radiation)
Lab requirements
Blood counts
ANC >=1,500/microliter (no G-CSF support); platelets >=100,000/microliter; Hgb >=10 g/dL (no pRBC transfusions)
Kidney function
Creatinine <1.5 x ULN OR CrCl (or eGFR) >45 mL/min/1.73 m^2 if creatinine >1.5 x ULN
Liver function
AST/ALT <=2.5 x ULN; total bilirubin <=1.5 x ULN (or <=3.0 ULN in Gilbert's syndrome); serum albumin >=2.8 g/dL
Participants must have adequate organ and marrow function as defined below: ANC >=1,500/microliter, without G-CSF support; Platelets >=100,000/microliter; AST/ALT <=2.5 x ULN; Hgb >= 10 g/dL (no pRBC transfusions); 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 CrCl (or eGFR) > 45 mL/min/1.73 m^2 if creatinine > 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06096870 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received definitive local therapy.
Does this trial require KLK3?
Yes, KLK3 doubling time < 12 months is a required biomarker for enrollment.
Does this trial require AR?
Yes, AR testosterone >100 ng/dl is a required biomarker for enrollment.
Does this trial require FOLH1?
Yes, FOLH1 psma positive by pet/ct is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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