A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer. - PROSTY trial

Phase 1

• Conditions: Metastatic Hormone Refractory Prostate Cancer.; MedDRA version: 8.1Level: PTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2004-004295-37-IE
• Lead Sponsor: All-Ireland Cooperative Oncology Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-17
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 360

Inclusion Criteria

Inclusion Criteria:
(1) Histologically/ cytologically proven adenocarcinoma of prostate.
(2) Metastatic disease (confirmed by imaging or clinical examination)
(3) Hormone refractory prostate cancer defined as rising PSA values in 2 sequential measurements
(4) Testosterone levels must be within the institutions castration levels.
(5) PSA > 10 µg/l
(6) No previous cytostatic treatment except estramustine phosphate which should be stopped =3 weeks before starting trial medication.
(7) Anti-androgen treatment must be stopped =3 weeks before starting trial medication.
(8) WHO performance status < or = 2
(9) Age > 18 years
(10) Laboratory requirements :
(a) Haematology :
- neutrophils > or = 1.5 x 10 to the power of 9 /l
- hemoglobin > or = 110 g/l , HB > 100 g/l in Sweden
- platelets > or = 100 x 10 to the power of 9 /l
(b) Hepatic function :
- total bilirubin < or = 1 x UNL
- ALAT and ASAT < or = 2.5 x UNL, Alk. Phos < or = 6 x UNL. In the presence of extensive bone disease, Alk. Phos is > 6 x UNL, the patient should be eligible in the study.
(c) Renal function :
-Creatinine < or = 1.5 x UNL (ie NCI grade < or = 1)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria:
(1) Less than 4 weeks since the completion of surgery.
(2) Prior radiotherapy > 25% of bone marrow
(3) Less than 3 weeks since estramustine phosphate treatment
(4) Prior therapy with radioisotopes
(5) Other malignant disease/ malignancy (except basalioma) within the past 5 years.
(6) Serious liver disease
(7) Other serious illness or medical condition:
(a)Serious cardiac disease; ischemic or tromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months
(b)Active infection
(c)Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of
corticosteroids.
(d)Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified