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NCT01531205 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA

A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT01531205: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT01531205 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01531205, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

The aim of this study is to test whether adding chemotherapy/cabazitaxel and hormonal/androgen deprivation therapy before surgical removal of your prostate would improve the outcome of salvage surgery for locally recurrent prostate cancer after the initial primary radiation therapy.

Primary Outcome

Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesti

Interventions

  • DRUG Cabazitaxel
  • DRUG Androgen Ablation
  • DRUG Salvage Therapy
  • DRUG Neoadjuvant Treatment - Hormonal Therapy
  • DRUG Neoadjuvant Treatment - Cabazitaxel

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2012-05
Est. Completion 2013-10
Phase Phase 2

Why NCT01531205 stopped before completion

NCT01531205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 5 interventions - of which Cabazitaxel is the first listed.

NCT01531205 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01531205 about?

NCT01531205 is a clinical study titled "Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA". The aim of this study is to test whether adding chemotherapy/cabazitaxel and hormonal/androgen deprivation therapy before surgical removal of your prostate would improve the outcome of salvage surgery for locally recurrent prostate cancer after the initial primary radiation therapy.

What is the current status of trial NCT01531205?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2012-05. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01531205?

The interventions under investigation include: Cabazitaxel (DRUG), Androgen Ablation (DRUG), Salvage Therapy (DRUG), Neoadjuvant Treatment - Hormonal Therapy (DRUG), Neoadjuvant Treatment - Cabazitaxel (DRUG).

Who is sponsoring clinical trial NCT01531205?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01531205's enrollment target sits among peer trials

2 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01531205, the US trial registry maintained by the National Library of Medicine. NCT01531205 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.