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NCT00005044 · ClinicalTrials.gov registry record · Phase 3

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
1,579
Enrollment target

NCT00005044: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00005044 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 1,579 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005044, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
1,579 participants
Enrollment target

Study Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Primary Outcome

Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or

Interventions

  • DRUG LHRH agonist
  • RADIATION radiation therapy
  • DRUG Casodex
  • DRUG Eulexin

Trial Details

FieldValue
Enrollment Target 1,579 participants
Start Date 2000-02
Est. Completion 2022-05-20
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00005044 record still lists

NCT00005044 is an interventional study that assigns participants to a tested intervention. Its 1,579 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (105% higher).

The record links to 0 conditions, and to 4 interventions - of which LHRH agonist is the first listed.

NCT00005044 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005044 about?

NCT00005044 is a clinical study titled "Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer". RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is mor...

What is the current status of trial NCT00005044?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,579 participants. The study started on 2000-02. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT00005044?

The interventions under investigation include: LHRH agonist (DRUG), radiation therapy (RADIATION), Casodex (DRUG), Eulexin (DRUG).

Who is sponsoring clinical trial NCT00005044?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00005044's enrollment target sits among peer trials

1,579 149th of 2000 higher than 1,852 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00005044, the US trial registry maintained by the National Library of Medicine. NCT00005044 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.