NCT06134232 Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
| NCT ID | NCT06134232 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dendreon |
| Condition | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2023-10-02 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria: For a subject to be eligible for participation in this study, all of the following criteria must be satisfied: 1. 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). 2. Have qualified for on-label PROVENGE® infusion 3. Have received all 3 infusions of PROVENGE® prior to randomization 4. Written informed consent provided prior to the initiation of study procedures 5. Estimated life expectancy ≥12 months Exclusion Criteria: A subject will not be eligible for participation in this study if any of the following criteria apply. 1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. 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) 3. 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. 4. On experimental or investigational therapy.
Contact & Investigator
Nadeem Sheikh, PhD
STUDY DIRECTOR
Dendreon Pharmaceuticals, LLC
Frequently Asked Questions
Who can join the NCT06134232 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-Resistant Prostate Cancer (mCRPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06134232 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06134232 currently recruiting?
Yes, NCT06134232 is actively recruiting participants. Contact the research team at ProvONE@dendreon.com for enrollment information.
Where is the NCT06134232 trial being conducted?
This trial is being conducted at Tuscon, United States, Duarte, United States, Fresno, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT06134232 clinical trial?
NCT06134232 is sponsored by Dendreon. The principal investigator is Nadeem Sheikh, PhD at Dendreon Pharmaceuticals, LLC. The trial plans to enroll 400 participants.
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