A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel (RisingPSA)

September 30, 2008 updated by: Assistance Publique - Hôpitaux de Paris

Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).

The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these recurrences occurring within the first 2 years.A prospective, multicenter, national, randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment (radical prostatectomy or radiotherapy).

  1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
  2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically documented adenocarcinoma of the prostate
  • Previous treatment with either radical prostatectomy or radiation therapy
  • Salvage radiotherapy for local relapse allowed
  • Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA
  • Life expectancy of more than 12 months
  • Non metastatic disease documented by imaging including radionuclide bone scan
  • ECOG performance status 0-1
  • ANC > 1,500/mm3
  • Platelet counts > 100,000/mm3
  • SGOT and/or SGPT may be up to 2.5 x ULN

Patients at high risk of biological relapse defined by:

  • Gleason > 8
  • PSA-DT < 6 months
  • Positive surgical margins
  • PSA velocity > 0.75 ng/mL/year
  • Pathological pelvic lymph nodes involvement (pN+)
  • Time from initial treatment until inclusion < 12 months

Exclusion Criteria:

  • Prior chemotherapy by taxanes and estramustine phosphate
  • Documented local recurrence of prostate cancer or documented metastatic disease
  • History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin
  • Active infection
  • Significant cardiac disease, angina pectoris or myocardial infarction within twelve months
  • Clinically significant neuropathy
  • Medical condition requiring the use of concomitant corticosteroids
  • Prohibited concomitant therapy with experimental drug.
  • Participation in another clinical trial for the period < 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Hormonal treatment (LH-RH agonist)
Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.
EXPERIMENTAL: 1
Drug: Docetaxel + hormonal treatment (LH-RH agonist)

Docetaxel will be administered:

  • To D1 of every cycle in the dose of 70 mg/m²,
  • Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance).

Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
Time Frame: Every month during 5 years.
Every month during 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).
Time Frame: Every month during 5 years
Every month during 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

ARTIC group (oncologists and urologists association)

Investigators

  • Principal Investigator: Stephane Oudard, MD PhD, European Georges Pompidou Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (ANTICIPATED)

November 1, 2009

Study Completion (ANTICIPATED)

November 1, 2010

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (ESTIMATE)

October 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 03108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenocarcinoma of the Prostate

Clinical Trials on Docetaxel + hormonal treatment (LH-RH agonist)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe