Prostate CancerPhase 2NCT06096870
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
A Phase 2 study testing Enzalutamide and PDS01ADC in people with Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer, Recurrent Prostate Cancer, PET Positive
- What is being tested?
- Enzalutamide and PDS01ADC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
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.
Read more
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.
...
Read the detailed description
- Enzalutamide given with androgen deprivation therapy (ADT) is Food and Drug Administration (FDA) approved for the treatment of metastatic prostate cancer based on conventional computed tomography (CT) and Tc99 scan.
- Enzalutamide for 3 months (short course) given without ADT has demonstrated the ability to control prostate-specific antigen (PSA) in recurrent prostate cancer for nearly a year, delaying the need for additional therapy.
- Enzalutamide without ADT was very well tolerated in our previous study, a prerequisite for any therapy in recurrent disease where patients may not have symptoms from prostate cancer for 5-10 years.
- Enzalutamide without ADT demonstrated the ability to enhance natural killer (NK) cells and decrease myeloid-derived suppressor cells.
- PDS01ADC is an immunocytokine that binds to areas of necrotic tumors. Preclinical data have demonstrated that PDS01ADC delivery to the tumor is enhanced by cytotoxic therapies such as radiation and chemotherapy.
- PDS01ADC has been shown to be well tolerated and even induce PSA responses in patients with recurrent prostate cancer.
- PDS01ADC has also been able to enhance NK cells in prostate cancer patients.
- Higher levels of NK cells have been associated with better clinical outcomes in prostate cancer.
- Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging is now approved in recurrent prostate cancer. No trial has prospectively evaluated an anti-androgen therapy (e.g., enzalutamide) without ADT in this population. If changes in imaging are seen similar to the PSA responses noted previously, these findings may demonstrate the efficacy of enzalutamide-based regimens in recurrent prostate cancer.
- Given that enzalutamide is cytotoxic and will induce necrosis, there is a rationale to combine it with the necrosis-targeting agent PDS01ADC. The fact that both enhance NK cells, which have been associated with better clinical outcomes adds further rationale to this combination.
Objective:
-To determine if the combination of enzalutamide and immunotherapy (PDS01ADC) is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone in participants with PET Positive Recurrent Prostate Cancer (pprPC).
Eligibility:
- 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 plus disease, and his history consistent with prostate cancer as documented by the investigator.
- History of primary treatment for prostate cancer (either surgery or radiation).
- PSA doubling time within less than 1 year before treatment initiation.
- Testosterone >100 ng/dL.
- Age >=18 years.
- Evidence of prostate cancer on PSMA PET/CT scan.
- Negative Tc99 Bone Scan.
- No evidence of soft tissue disease on the CT scan (or MRI) per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Design:
- This is an open-label phase II clinical trial with two treatment arms: Arm 1 (enzalutamide) and Arm 2 (enzalutamide plus PDS01ADC).
- After enrollment, participants will be randomized between Arms 1 and 2 and receive 3 cycles of treatment of enzalutamide or enzalutamide and PDS01ADC.
- During off treatment monitoring period following the third cycle, participants who experience PSA recovery to baseline will have a second course of enzalutamide treatment only (3 cycles total).
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer, PET Positive
- Being tested
- Enzalutamide, PDS01ADC
- Keywords
- Combination Therapy, Recurrent Prostate Cancer, PET Positive, Enzalutamide, PDS01ADC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Enzalutamide at 160 mg once daily on every day of the cycle (every 28 days)
PDS01ADCDrug
PDS01ADC at 12.0 microgram/kg by subcutaneous injection (every 28 days)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Enzalutamide Receives: Drug: Enzalutamide |
| Arm 2 | Experimental | Enzalutamide+PDS01ADC Receives: Drug: Enzalutamide; Drug: PDS01ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (4)
PET changes after enzalutamide with and without PDS01ADC treatment
PET changes will be reported descriptively
Measured: 1 year
Safety of study treatment
Safety will be evaluated by determining the frequency of adverse events among treated participants and reporting the results, by maximum grade of event and type of toxicity noted
Measured: until 30 days after last dose of study drug
Evaluate immune response
Results of peripheral immune cell subsets including CD4 and CD8 T cells, NK cells, Tregs, and MDSCs measurements will be reported descriptively
Measured: 1 year
PSA detection
The proportion of participants with undetectable PSA at 12 months will be reported along with a 95% confidence interval
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start22 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Melissa L Abel, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096870
- Sponsor's protocol ID
- 10001556
- Other IDs
- 001556-C
- Status last verified
- 13 Oct 2026
- First submitted
- 21 Oct 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
- ClinicalTrials.gov ID
- NCT06096870
- Acronym / sponsor ID
- 10001556
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer, PET Positive
- Keywords
- Combination Therapy, Recurrent Prostate Cancer, PET Positive, Enzalutamide, PDS01ADC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
- Enzalutamide given with androgen deprivation therapy (ADT) is Food and Drug Administration (FDA) approved for the treatment of metastatic prostate cancer based on conventional computed tomography (CT) and Tc99 scan.
- Enzalutamide for 3 months (short course) given without ADT has demonstrated the ability to control prostate-specific antigen (PSA) in recurrent prostate cancer for nearly a year, delaying the need for additional therapy.
- Enzalutamide without ADT was very well tolerated in our previous study, a prerequisite for any therapy in recurrent disease where patients may not have symptoms from prostate cancer for 5-10 years.
- Enzalutamide without ADT demonstrated the ability to enhance natural killer (NK) cells and decrease myeloid-derived suppressor cells.
- PDS01ADC is an immunocytokine that binds to areas of necrotic tumors. Preclinical data have demonstrated that PDS01ADC delivery to the tumor is enhanced by cytotoxic therapies such as radiation and chemotherapy.
- PDS01ADC has been shown to be well tolerated and even induce PSA responses in patients with recurrent prostate cancer.
- PDS01ADC has also been able to enhance NK cells in prostate cancer patients.
- Higher levels of NK cells have been associated with better clinical outcomes in prostate cancer.
- Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging is now approved in recurrent prostate cancer. No trial has prospectively evaluated an anti-androgen therapy (e.g., enzalutamide) without ADT in this population. If changes in imaging are seen similar to the PSA responses noted previously, these findings may demonstrate the efficacy of enzalutamide-based regimens in recurrent prostate cancer.
- Given that enzalutamide is cytotoxic and will induce necrosis, there is a rationale to combine it with the necrosis-targeting agent PDS01ADC. The fact that both enhance NK cells, which have been associated with better clinical outcomes adds further rationale to this combination.
Objective:
-To determine if the combination of enzalutamide and immunotherapy (PDS01ADC) is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone in participants with PET Positive Recurrent Prostate Cancer (pprPC).
Eligibility:
- 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 plus disease, and his history consistent with prostate cancer as documented by the investigator.
- History of primary treatment for prostate cancer (either surgery or radiation).
- PSA doubling time within less than 1 year before treatment initiation.
- Testosterone >100 ng/dL.
- Age >=18 years.
- Evidence of prostate cancer on PSMA PET/CT scan.
- Negative Tc99 Bone Scan.
- No evidence of soft tissue disease on the CT scan (or MRI) per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Design:
- This is an open-label phase II clinical trial with two treatment arms: Arm 1 (enzalutamide) and Arm 2 (enzalutamide plus PDS01ADC).
- After enrollment, participants will be randomized between Arms 1 and 2 and receive 3 cycles of treatment of enzalutamide or enzalutamide and PDS01ADC.
- During off treatment monitoring period following the third cycle, participants who experience PSA recovery to baseline will have a second course of enzalutamide treatment only (3 cycles total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EnzalutamideEnzalutamide |
| Arm 2 | Experimental | Drug: Enzalutamide, Drug: PDS01ADCEnzalutamide+PDS01ADC |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideEnzalutamide at 160 mg once daily on every day of the cycle (every 28 days) | Drug | Arm 1, Arm 2 |
| PDS01ADCPDS01ADC at 12.0 microgram/kg by subcutaneous injection (every 28 days) | Drug | Arm 2 |
Primary outcome
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
Time frame: 5 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
4 secondary outcomes
PET changes after enzalutamide with and without PDS01ADC treatment
Time frame: 1 year
Safety of study treatment
Time frame: until 30 days after last dose of study drug
Evaluate immune response
Time frame: 1 year
PSA detection
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa L Abel, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide and PDS01ADC in people with Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy R Hankin, P.A.-C ((240) 858-3149, amy.hankin@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.