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NCT06100705 · ClinicalTrials.gov registry record · Phase 2

Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC

A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Yale University.

Recruiting
Registry status
Phase 2
Development phase
26
Enrollment target
1
Study location

NCT06100705 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 26 participants, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06100705, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
Phase 2
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).

Interventions

  • DRUG Testosterone Cypionate
  • DRUG Sipuleucel-T

Study Locations (1)

Connecticut

  • Yale Cancer Center - New Haven

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2023-12-20
Est. Completion 2028-03
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT06100705

The ClinicalTrials.gov registry entry for NCT06100705 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Testosterone Cypionate is the first listed.

NCT06100705 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT06100705 about?

NCT06100705 is a clinical study titled "Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC". This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and g...

What is the current status of trial NCT06100705?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-12-20. Estimated completion is 2028-03.

What conditions does trial NCT06100705 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT06100705?

The interventions under investigation include: Testosterone Cypionate (DRUG), Sipuleucel-T (DRUG).

Who is sponsoring clinical trial NCT06100705?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06100705 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.