To evaluate and compare progression free survival (PSA) between the two treatment arms.
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate and compare progression free survival (PFS) between the two
treatment arms.
Secondary outcome
To evaluate and compare
· Metastasis free survival
· Cancer specific survival
· Overall survival
· Quality of Life (QoL)
· PSA doubling time after progression
Background summary
Chemotherapy has historically been regarded as not effective for the treatment
of androgen independent prostate cancer. Only Taxotere (docetaxel) and
prednisone have recently been shown to confer a survival advantage to patients
with advanced disease, raising the possibility that chemotherapy may contribute
to the cure of patients when applied earlier in the natural history.
Study objective
To evaluate and compare progression free survival (PSA) between the two
treatment arms.
Study design
The trial is a prospective, open, multinational, multicentre, randomised phase
III trial.
Intervention
Arm A: Antiandrogen alone (bicalutamide 150 mg x 1)
Arm B: Antiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2
(max. 2.0 m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Docetaxel will
be given for up to 8-10 cycles or until unacceptable toxicity or consent
withdrawal whichever comes first.
Profylactic mammary gland irradiation should be given to all patients before
treatment starts.
Study burden and risks
The main side effects of docetaxel are neutropenia, anaphylactoid type
reactions, skin toxicity and nail disorders, digestive toxicity (oral
mucositis, nausea, vomiting and diarrhoea), peripheral neurotoxicity, alopecia,
asthenia/fatigue and peripheral oedema.
Patients receiving taxotere may have a longer progression free survival.
Skogstien 22
131 42 Nacka
SE
Skogstien 22
131 42 Nacka
SE
Listed location countries
Age
Inclusion criteria
- Men > 18 and <=80 years of age.
- WHO/ECOG performance status 0 - 1.
- Histological proven adenocarcinoma of the prostate.
- Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1) treatment,
· After Curative treatment
o Prostatectomy: PSA > 10 OR PSA DT < 12 months and PSA > 0.5 (PSA
doubling time calculation must start at a minimum value of > 0.5)
o Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT < 12 months
and PSA > 0.5. (PSA bouncing after radiotherapy should be excluded
according to the local traditions, and PSA doubling time calculation must start
at a minimum value of > 0.5)
· In locally advanced (or local not suitable for curative therapy) prostate
cancer patients, PSA < 100 is required before inclusion AND one of the following
o PSA DT < 12 months or
o PSA >20 or
o Gleason score 8-10,
- Previous hormonal therapy in conjunction with radiotherapy is allowed, provided
that the total duration of therapy does not exceed 12 months and has to be
stopped > 12 months ago.
- Testosterone value > 5 nmol/l
- Adequate haematological-, liver- and kidney function.
- Negative bone scan performed no more than 3 months prior to randomisation.
- Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional
- Written informed consent.
Exclusion criteria
- Positive Bone scan.
- Any distant metastasis detected by CT or ultrasound.
- 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 5 years.
- Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad.
- 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.
- Symptomatic peripheral neuropathy >= CTCAE grade 2.
- Patients who by altered physical or psychological state not are able to co-operate
or participate in the trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003138-33-NL |
| CCMO | NL28063.078.09 |