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NCT01546987 · ClinicalTrials.gov registry record · Phase 3

Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

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

Completed
Registry status
Phase 3
Development phase
239
Enrollment target
20
Study locations

NCT01546987: Completed Phase 3 study of Prostate Cancer, sponsored by Radiation Therapy Oncology Group.

NCT01546987 is a Phase 3 study of Prostate Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 239 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01546987, a Phase 3 study of Prostate Cancer, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
239 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer. PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

Primary Outcome

Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing ri

Conditions Studied

Prostate Cancer

Interventions

  • RADIATION Radiation therapy
  • DRUG GnRH agonist
  • DRUG Anti-androgen
  • DRUG TAK-700

Study Locations (20)

California

  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
  • Mercy San Juan Medical Center - Carmichael
  • Veterans Administration Long Beach Medical Center - Long Beach
  • Los Angeles County-USC Medical Center - Los Angeles
  • University of Southern California/Norris Cancer Center - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles
  • Pomona Valley Hospital Medical Center - Pomona
  • Rohnert Park Cancer Center - Rohnert Park
  • Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
  • Sutter General Hospital - Sacramento
  • University of California At San Diego - San Diego
  • UCSF-Mount Zion - San Francisco
  • Kaiser Permanente Medical Center - Santa Clara - Santa Clara
  • Kaiser Permanente Cancer Treatment Center - South San Francisco
  • Stanford University Hospitals and Clinics - Stanford

Alabama

  • The Kirklin Clinic at Acton Road - Birmingham
  • University of Alabama at Birmingham - Birmingham

Arizona

  • Arizona Oncology-Deer Valley Center - Phoenix
  • Arizona Oncology Services Foundation - Scottsdale

Trial Details

FieldValue
Enrollment Target 239 participants
Start Date 2012-05
Est. Completion 2025-09-04
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT01546987 record still lists

NCT01546987 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower).

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Radiation therapy is the first listed.

NCT01546987 names 20 study sites across 3 states, led by California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01546987 about?

NCT01546987 is a clinical study titled "Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer". RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective...

What is the current status of trial NCT01546987?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2012-05. Estimated completion is 2025-09-04.

What conditions does trial NCT01546987 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01546987?

The interventions under investigation include: Radiation therapy (RADIATION), GnRH agonist (DRUG), Anti-androgen (DRUG), TAK-700 (DRUG).

Who is sponsoring clinical trial NCT01546987?

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

Where is trial NCT01546987 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostate Cancer

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 NCT01546987's enrollment target sits among peer trials

239 195th of 735 higher than 541 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer 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 NCT01546987, the US trial registry maintained by the National Library of Medicine. NCT01546987 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.