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Prostate CancerPhase 2NCT05751941

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

A Phase 2 study testing Abiraterone, Enzalutamide and Apalutamide in people with Prostate Cancer and Metastatic Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metastatic Prostate Cancer
What is being tested?
Abiraterone, Enzalutamide and Apalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
14 Feb 2023to Dec 2026
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion
  • On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria
  • Age 18 or above
  • ECOG performance status 0 or 1
  • Participants must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,000/mcL
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  • Platelets ≥100,000/mcL
  • Hemoglobin > 10 g/dl
  • AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
  • Creatinine 1.5 ≤ institutional ULN
  • Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of sipuleucel-T are eligible for this trial
  • No uncontrolled arrhythmia: patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment
  • Non-sterilized men who are sexually active with a female partner of childbearing potential must agree to use adequate contraception prior to the study enrollment, and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Prior treatment with sipuleucel-T
  • Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2).
  • Participants who require > 50% dose reduction of NHA are excluded from the study except for taking abiraterone at 250 mg with low fat food
  • Documented brain metastases or liver metastases
  • Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T
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  • Documented brain metastases or liver metastases
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for sipluleucel-T to be less clinically active in this population
  • Inability to comply with protocol requirements

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.

Being tested
Abiraterone, Enzalutamide, Apalutamide, Sipuleucel-T
Keywords
PSA Progression
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbirateroneDrug

    1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily

  • EnzalutamideDrug

    Also called Xtandi

    160 mg of Enzalutamide will be given orally daily ending at week 4

  • ApalutamideDrug

    240 mg of Apalutamide will be given orally daily ending at week 4

  • Sipuleucel-TDrug

    Also called Provenge

    Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.

Study groups in NCT05751941
Study groupRoleWhat they receive
Sipuleucel-T with NHAExperimentalParticipants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Receives: Drug: Abiraterone; Drug: Enzalutamide; Drug: Apalutamide; Drug: Sipuleucel-T
Sipuleucel-T without NHAExperimentalParticipants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Receives: Drug: Sipuleucel-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative APC Activation

    Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks

    Measured: At Week 4

Secondary outcomes (3)

  1. Time to PSA progression

    PSA progression will be defined as the time from randomization to the first date of documented PSA progression based on the prostate cancer working group (PCWG) 3 criteria.

    Measured: Up to week 44

  2. Radiographic Progression Free Survival

    Radiographic Progression Free Survival (rPFS) as assessed by conventional CT and bone scan

    Measured: Up to week 44

  3. IgG Responses

    To evaluate increases in IgG levels after treatment, pre- and post treatment signal intensities from Luminex xMAP will be compared using a one-sided paired Wilcoxon signed-rank test. To evaluate whether the fold changes in IgG levels after treatment were higher in the NHA group than the without NHA group, the values from the two groups will be compared using a one-sided Wilcoxon rank-sum test.

    Measured: At week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start14 Feb 2023
  3. Primary completion4 Jul 2026
  4. Study completionDec 2026 (estimated)

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05751941
Sponsor's protocol ID
MCC-22003
Status last verified
Sep 2026
First submitted
21 Feb 2023
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone, Enzalutamide and Apalutamide in people with Prostate Cancer and Metastatic Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 17 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative APC Activation (time frame: At Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05751941.

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 15 Sep 2026.

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