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

Prostate Cancer Clinical Trial

— AdRad  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00653848
• Other study ID #: SPCG-13
• Secondary ID: 2006-001657-94
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2021
• Source: Scandinavian Prostate Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 378
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Jon R Iversen	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Scandinavian Prostate Cancer Group	Sanofi

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA progression rate	According to RTOG-ASTRO guidelines	From randomization to progression
Secondary	PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival	PSA doubling measured, FACT-P, detection of metastatic lesions	From randomisation to year 2014