Metastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 2ProvONENCT06134232
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
A Phase 2 study testing Sipuleucel-T Injection in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Dendreon at 31 sites in United States.
Trial summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- What is being tested?
- Sipuleucel-T Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 31 sitesUnited States
- Study dates
- 2 Oct 2023to 30 Jun 2032
- 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
- For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
- Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Have qualified for on-label PROVENGE® infusion
- Have received all 3 infusions of PROVENGE® prior to randomization
- Written informed consent provided prior to the initiation of study procedures
- Estimated life expectancy ≥12 months
Who cannot join
- A subject will not be eligible for participation in this study if any of the following criteria apply.
- Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
- Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
- On experimental or investigational therapy.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites, 30 recruiting
- Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Laurence Belkoff, MD, 610 667 0458, lbelkoff@midlanticurology.com
- Recruiting
Urology of Indiana
Carmel, Indiana, 46032
Kenneth Ney, MD, 317 564 5159, kney@urologyin.com
- Recruiting
Lowcountry Urology Institute
Charleston, South Carolina, 29406
Justin Ellett, MD, 843 572 1010, jellett@lcurology.com
- Active, not recruiting
Associated Urological Specialists
Chicago Ridge, Illinois, 60415
- Recruiting
The Urology Group
Cincinnati, Ohio, 45212
Mark Pliskin, MD, 513 841 7550, mpliskin@urologygroup.com
- Recruiting
Advanced Urology Institute
Daytona Beach, Florida, 32114
Evan Fynes, MD, 386 239 8500, Evan.fynes@auihealth.com
- Recruiting
City of Hope - National Medical Center
Duarte, California, 91010
Tanya Dorff Principal Investigator, MD, 626-218-6585, mtuano@coh.org
- Recruiting
Urology Associates of Central California Medical Group
Fresno, California, 93720
William Schiff, MD, 559 321 2800, drschiff@urologyassociates.net
- Recruiting
Central Ohio Urology Group
Gahanna, Ohio, 43230
Benjamin Martin, MD, 614 396 2684, bmartin@centralohiourology.com
- Recruiting
UroPartners
Glenview, Illinois, 60026
Jeffrey Pearl, MD, 847-823-3185, jpearl@uropartners.com
- Recruiting
First Urology
Jeffersonville, Indiana, 47130
Ryan Malone, MD, 812-670-2755, rmalone@1sturology.com
- Recruiting
Colorado Urology
Lakewood, Colorado, 80228
David Cahn, MD, 303-996-9649, dcahn@coloradouro.com
- Recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
Paul Sieber, MD, 717 431 2285, krisb@midlanticurology.com
- Recruiting
Advanced Urology Institute
Largo, Florida, 33771
Matthew Truesdale, MD, 813 245 3782, matthew.truesdale@auihealth.com
- Recruiting
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410
Manoj Rao, MD, 219 259 1291, mrao@urologic-specialists.com
- Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Neal Shore, MD, 843-449-1010 ext. 5268, kate.valipour@startresearch.com
- Recruiting
Urology Associates of Nashville
Nashville, Tennessee, 37209
David Morris, MD, 615-250-9268, ctrotter@ua-pc.com
- Recruiting
Advanced Urology Associates
New Lenox, Illinois, 60451
Greg Andros, MD, 815 409 4930, DrAndros@advuro.com
- Recruiting
Integrated Medical Professionals
North Hills, New York, 11040
Jed Kaminetsky, MD, 212 480 3333, jkaminetsky@imppllc.com
- Recruiting
Advanced Urology Institute
Ocala, Florida, 34471
Edward King, MD, 352 430 0705, edward.king@auihealth.com
- Recruiting
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Mark Jalkut, MD, 919 390 7368, mjalkut@gmail.com
- Recruiting
Florida Urology Partners
Riverview, Florida, 33578
Alexander Engelman, MD, 813-981-3931, aengelman@floridaurologypartners.com
- Recruiting
Unio Health Partners - Genesis Research, LLC
San Diego, California, 92123
Paul Dato, MD, 858 279 7050 ext. 2676, Paul.Dato@UnioHP.com
- Recruiting
Spokane Urology
Spokane, Washington, 99202
Raymond Lance, MD, 509 747 3147 ext. 112, Amyb@spokaneurology.com
- Recruiting
Oregon Urology Institute
Springfield, Oregon, 97477
Bryan Mehlhaff, MD, 541 284 5508, bryan@oregonurology.com
- Recruiting
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141
Brittany Minor, 314-806-3921, brittany.minor@objective.health
- Recruiting
Associated Medical Professionals of NY
Syracuse, New York, 13210
Christopher Pieczonka, MD, 315 558 6619, cpieczonka@ampofny.com
- Recruiting
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Ronald Tutrone, MD, 443 471 5741, rtutrone@uniteduro.com
- Recruiting
Michigan Institute of Urology
Troy, Michigan, 48084
Jason Hafron, MD, 248 786 0467, hafronj@michiganurology.com
- Recruiting
Arizona Urology Specialists
Tuscon, Arizona, 85741
Kalpesh Patel, MD, 520 618 1010, kpatel@arizonauro.com
- Recruiting
Urology of Virginia
Virginia Beach, Virginia, 23462
Robert Given, MD, 757 452 3486, abohannon@urologyofva.net
About this study
Official title: An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Read the detailed description
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.
- Being tested
- Sipuleucel-T Injection
- Keywords
- Single Dose, Sipuleucel-T, Immune Response Rate, Safety, Adenocarcinoma of the Prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sipuleucel-T InjectionDrug
Single Infusion
| Study group | Role | What they receive |
|---|---|---|
| Booster Arm | Experimental | Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion.
Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events. Receives: Drug: Sipuleucel-T Injection |
| No Booster | No intervention | No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess humoral immune response to PAP and PA2024 after booster infusion
To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not
Measured: Once all subjects have completed the study through the 5 year Overall Survival Period
Secondary outcomes (2)
Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups.
Measured: Once all subjects have completed the study through the 5 year Overall Survival Period
Evaluate Overall Survival
Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause.
Measured: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Oct 2023
- Primary completion31 Dec 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- 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
- Model description
- AN OPEN-LABEL, MULTICENTER STUDY OF SUBJECTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER TREATED WITH PROVENGE AND BOOSTED WITH A SINGLE INFUSION OF SIPULEUCEL-T TO MEASURE IMMUNE RESPONSE
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCG IRB, Talosix
- Responsible party
- Sponsor
- Investigators
- Nadeem Sheikh, PhD, Study director, Dendreon Pharmaceuticals, LLCBenjamin Lowentritt, MD, Study chair, Chesapeake Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134232
- Sponsor's protocol ID
- P23-1
- Acronym
- ProvONE
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Based on precedent, only IPD used in the results publication may be shared; however, the internal Dendreon team has not yet discussed this.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response
- ClinicalTrials.gov ID
- NCT06134232
- Acronym / sponsor ID
- ProvONE / P23-1
- Keywords
- Single Dose, Sipuleucel-T, Immune Response Rate, Safety, Adenocarcinoma of the Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Collaborators
- WCG IRB, Talosix
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 18 Nov 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.
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Detailed description
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AN OPEN-LABEL, MULTICENTER STUDY OF SUBJECTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER TREATED WITH PROVENGE AND BOOSTED WITH A SINGLE INFUSION OF SIPULEUCEL-T TO MEASURE IMMUNE RESPONSE
| Arm | Type | Receives |
|---|---|---|
| Booster Arm | Experimental | Drug: Sipuleucel-T InjectionExperimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events. |
| No Booster | No intervention | –No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
- Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Have qualified for on-label PROVENGE® infusion
- Have received all 3 infusions of PROVENGE® prior to randomization
- Written informed consent provided prior to the initiation of study procedures
Key exclusion criteria (5 listed)
- A subject will not be eligible for participation in this study if any of the following criteria apply.
- Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
- Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
- On experimental or investigational therapy.
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 |
|---|---|---|
| Sipuleucel-T InjectionSingle Infusion | Drug | Booster Arm |
Primary outcome
Assess humoral immune response to PAP and PA2024 after booster infusion
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period
To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not
2 secondary outcomes
Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period
Evaluate Overall Survival
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating
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 27 Aug 2025.
- Dendreon Clinical Trial Summary WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Based on precedent, only IPD used in the results publication may be shared; however, the internal Dendreon team has not yet discussed this.
Related trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
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.
Nadeem Sheikh, PhD study director
Dendreon Pharmaceuticals, LLC
Benjamin Lowentritt, MD study chair
Chesapeake Urology
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sipuleucel-T Injection in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Dendreon at 31 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 6 inclusion and 5 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
Contact Margaret Warner-Lubin (2064588358, ProvONE@dendreon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess humoral immune response to PAP and PA2024 after booster infusion (time frame: Once all subjects have completed the study through the 5 year Overall Survival Period). 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 27 Aug 2025.