Treatment of Prostate Cancer With Docetaxel + Hormonal Treatment Versus Hormonal Treatment in Patients Treated With Radical Radiotherapy - Full Text View

Purpose

As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel	Phase III

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Docetaxel Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-Risk Prostate Cancer Treated With Radical Radiotherapy

Further study details as provided by Scandinavian Prostate Cancer Group:

Primary Outcome Measures:

PSA progression rate [ Time Frame: From randomization to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival [ Time Frame: From randomisation to year 2014 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	924
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Docetaxel arm: Experimental six of docetaxel every third week + hormonal treatment	Drug: docetaxel docetaxel 75 mg/square meter i.v. every third week, six cycles
Control: No Intervention hormonal treatment only

Detailed Description:

Primary endpoint:

PSA progression rate, ASTRO guidelines.

Secondary endpoints:

PSA doubling time after progression
Quality of Life (QoL)
Safety
Metastases free survival
Overall survival

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men > 18 and ≤75 years of age.
WHO/ECOG performance status 0 - 1.
Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation
One of the following:
- T2 with Gleason score 7(4+3 ) and PSA >10 ng/ml to < 70 ng/ml
- T2 with Gleason 8-10, any PSA < 70 ng/ml
- any T3 tumour
Prior neoadjuvant hormone therapy is mandatory for all patients
Adequate haematological-, liver- and kidney function. (Hemoglobin > 110 g/l, neutrophils > 1.5 x 109/ l, platelets > 150 x 109/ l, ASAT and ALAT < 1.5 x ULN, ALP < 1.5 x ULN, creatinine < 1.5 x ULN)
Written informed consent

Exclusion Criteria:

M+
N+ clinical or pathological
Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years.
Previous radiotherapy to the pelvic region.
Previous chemotherapy within 5 years.
Systemic corticosteroids within 6 months prior to randomisation.
Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
Active untreated infectious disease, including tuberculosis, MRSA.
Active gastric ulcer.
Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
Other serious illness or medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653848

Contacts


Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, Prof	+358505951103	Pirkko-liisa.Kellokumpu-Lehtinen@uta.fi

Contact: Claes Ginman, MD	+4654655000	Claes.Ginman@liv.se

Locations


Norway
	Jon R Iversen	Recruiting
	Oslo, Norway
	Contact: Jon R Iversen

Sponsors and Collaborators

Scandinavian Prostate Cancer Group

Sanofi-Aventis

Investigators


Principal Investigator:	Pirkko-Liisa i Kellokumpu-Lehtinen, Prof	TampereUH

More Information

Responsible Party:	Tampere University Hospital ( Pirkko-Liisa Kellokumpu-Lehtinen, professor )
Study ID Numbers:	SPCG-13, EudraCT 2006-001657-94
First Received:	April 2, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00653848
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Scandinavian Prostate Cancer Group:

Adjuvant treatment, intermediate and high risk, radical radiotherapy

Study placed in the following topic categories:

Docetaxel

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Scandinavian Prostate Cancer Group Sanofi-Aventis
Information provided by:	Scandinavian Prostate Cancer Group
ClinicalTrials.gov Identifier:	NCT00653848