---
title: "The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation"
nct_id: NCT01981668
overall_status: WITHDRAWN
phase: PHASE1
sponsor: Nova Scotia Cancer Centre
study_type: INTERVENTIONAL
primary_condition: Prostatic Neoplasms
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01981668.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01981668"
ct_last_update_post_date: 2014-03-19
last_seen_at: "2026-05-12T06:51:09.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation

**NCT ID:** [NCT01981668](https://clinicaltrials.gov/study/NCT01981668)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** no Canadian centre interested in conducting study in a reasonable timeframe
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Nova Scotia Cancer Centre
- **Collaborators:** Sanofi
- **Conditions:** Prostatic Neoplasms
- **CT.gov Last Update:** 2014-03-19

## Brief Summary

This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

## Detailed Description

This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

Assuming that dose-limiting toxicity is not encountered, and both the maximum dose of Cabazitaxel is reached, in Part A of the study, and the maximum dose of Radiotherapy is reached in Part B of the study, the maximum number of patients required is as follows: Clinical Study Protocol - The JET study Date: September 11, 2012 Part A: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of Cabazitaxel = 15 + 3 = 18 Part B: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of Radiotherapy = 9 + 3 = 12 The total number of patients required is 30. Patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than DLT will be replaced.

Given our experience in chemo-radiation studies in a similar patient population, our Centre is anticipated to accrue 3 patients per month.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* High risk prostate cancer

Exclusion Criteria:

* mets
```

## Arms

- **Cabazitaxel, Eligard and Radiotherapy** (EXPERIMENTAL) — This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the MTD of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

## Interventions

- **cabazitaxel** (DRUG) — Concurrent cabazitaxel, radiotherapy and Eligard for 3 years

## Primary Outcomes

- **Toxicity** _(time frame: 1 year)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01981668*  
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