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NCT06305598 · ClinicalTrials.gov registry record · Phase 1

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Roswell Park Cancer Institute.

Recruiting
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT06305598 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 14 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06305598, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.

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

Study Summary

This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

Interventions

  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Bone Scan
  • DRUG Leuprolide Acetate

Study Locations (1)

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2024-12-19
Est. Completion 2027-12-15
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

365 total trials

What the Registry Record Tells You About NCT06305598

The ClinicalTrials.gov registry entry for NCT06305598 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (92% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.

NCT06305598 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT06305598 about?

NCT06305598 is a clinical study titled "Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer". This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regula...

What is the current status of trial NCT06305598?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2024-12-19. Estimated completion is 2027-12-15.

What conditions does trial NCT06305598 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma.

What interventions are being tested in trial NCT06305598?

The interventions under investigation include: Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Leuprolide Acetate (DRUG).

Who is sponsoring clinical trial NCT06305598?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06305598 being conducted?

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

Similar trials for Stage IVB Prostate Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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

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