Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

NCT00653848 | Unknown Phase 3 DMC

• 2 other identifiers: SPCG-132006-001657-94
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Adjuvant treatment, high risk, radical radiotherapy

Outcome Measures

Primary Outcomes (1)

• PSA progression rate

  According to RTOG-ASTRO guidelines

  From randomization to progression

Secondary Outcomes (1)

• PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival

  From randomisation to year 2014

Study Arms (2)

Docetaxel arm

EXPERIMENTAL

six of docetaxel every third week + hormonal treatment

Drug: docetaxel

Control

NO INTERVENTION

hormonal treatment only

Interventions

docetaxel DRUG

docetaxel 75 mg/square meter i.v. every third week, six cycles

Also known as: LHRH ananlog 9 months

Docetaxel arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scandinavian Prostate Cancer Group: lead
• Sanofi: collaborator

Study Sites (1)

Jon R Iversen

Oslo, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Pirkko-Liisa i Kellokumpu-Lehtinen, Prof

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: May 1, 2007
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

NO (1)