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NCT04267887 · ClinicalTrials.gov registry record · Phase 2

Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, sponsored by OHSU Knight Cancer Institute.

Active
Registry status
Phase 2
Development phase
7
Enrollment target
1
Study location

NCT04267887: Active Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, sponsored by OHSU Knight Cancer Institute.

NCT04267887 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 7 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04267887, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Carcinoma, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Primary Outcome

The complete PSA response is defined as a PSA =\< 0.2 ng/ml, confirmed with a 2nd measurement at least 3 weeks later. The estimated PSA response rate will be computed with 95% exact confidence interval. Binomial exact test will be used to determine whether the complete PSA response rate is significantly greater than 43%.

Conditions Studied

Stage IVB Prostate Cancer AJCC v8 Metastatic Prostate Carcinoma Castration-Sensitive Prostate Carcinoma

Interventions

  • PROCEDURE Computed Tomography
  • DRUG Apalutamide
  • DRUG Antiandrogen Therapy
  • DRUG Prednisone
  • DRUG Abiraterone Acetate

Study Locations (1)

Oregon

  • OHSU Knight Cancer Institute - Portland

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2020-05-11
Est. Completion 2030-01-01
Phase Phase 2
OHSU Knight Cancer Institute

211 total trials

What the registry record for NCT04267887 still lists

NCT04267887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (96% lower).

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.

NCT04267887 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT04267887 about?

NCT04267887 is a clinical study titled "Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer". This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration se...

What is the current status of trial NCT04267887?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2020-05-11. Estimated completion is 2030-01-01.

What conditions does trial NCT04267887 study?

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

What interventions are being tested in trial NCT04267887?

The interventions under investigation include: Computed Tomography (PROCEDURE), Apalutamide (DRUG), Antiandrogen Therapy (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG).

Who is sponsoring clinical trial NCT04267887?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04267887 being conducted?

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

Learn More About Clinical Trials

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.

Where NCT04267887's enrollment target sits among peer trials

7 44th of 45 higher than 1 of 45 other Stage IVB Prostate Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04267887, the US trial registry maintained by the National Library of Medicine. NCT04267887 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.