Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Clinical Trial

— ProvONE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134232
• Other study ID #: P23-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 27, 2023
• Est. completion date: June 30, 2032

Study information

• Verified date: November 2023
• Source: Dendreon
• Contact: Margaret Warner-Lubin
• Phone: 2064588358
• Email: ProvONE[@]dendreon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2032
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids).

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.

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Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Drug:
• Sipuleucel-T Injection
Single Infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess biomarkers of response to treatment	Biomarkers, such as cytokines, will be assessed for response to booster treatment using appropriate descriptive statistics assessed over time and at Week 28. Nominal p-values will be provided without multiplicity adjustment .appropriate descriptive statistics assessed over time and at Week 28.	Once all subjects have completed the study through the 5 year Overall Survival Period
Other	Assess Antigen Response	Comparison of (over time and at Week 38), the number of subjects per treatment arm with PAP and PA2024 antigen antigen positive response using descriptive statistics.	Once all subjects have completed the study through the 5 year Overall Survival Period
Primary	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	Once all subjects have completed the study through the 5 year Overall Survival Period
Primary	Geometric Mean Ration of the difference in Humor Response	The difference in humoral response to PAP and/or PA2024 after booster infusion (measured approximately 2 weeks after receipt of booster) assessed by Geometric Mean Ratio of the difference between humoral response at each timepoint and after booster within and between the groups.Subjects will be evaluated for IgG and IgM antibody responses by an Enzyme-Linked Immunosorbent Assay (ELISA) and both the antibody titer as well as percent maintaining an antibody response, as determined by number of subjects with an antibody titer greater that the 9th percentile at baseline, will be compared between booster and control arms	Once all subjects have completed the study through the 5 year Overall Survival Period
Secondary	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.	Once all subjects have completed the study through the 5 year Overall Survival Period