A Single Arm Phase II Study to assess the efficacy of intensified intravenous Melphalan in combination with a transplant of the patient's own blood stem cells for a maximum of three cycles in patients with castration-resistant prostate cancer (CRPC)
- Conditions
- castration resistant prostate cancer patientsTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2012-000351-14-GB
- Lead Sponsor
- Barts Health NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 29
1.Men aged =18 years
2.Histological diagnosis of prostate cancer
3.Progressive Castration-resistant Prostate Cancer defined as:
•a rising PSA; or
•development of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or
•if testosterone >1.5nmol/l, maximum androgen blockade failure (MAB)
(MAB = GnRH analogue and peripheral anti-androgen – flutamide 250mg 3x/day or bicalutamide 50mg/day or cyproterone 100mg 3x/day)
4.ECOG performance status 0-2
5.Adequate haematological reserve
•Unsupported Hb >10.0 g/l
•Platelets >100x109/l
•WBC >3x109/l
•Neutrophils >1.5x109/l
6.Renal sufficiency:
•Creatinine <200 µmol/l
7.Hepatic sufficiency:
•Bilirubin <30 µmol/l
•ALT <3xULN unless due to liver metastasis
8.Able to give written informed consent and comply with the protocol study procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Patients who have suffered a previous hypersensitivity reaction to melphalan
2.Patients with known hypersensitivity to lenograstim or to any of the excipients
3.History of myeloid malignancy
4.Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)
5.Previous invasive carcinoma <3 years prior to study entry
6.Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
7.Current treatment with another investigational medicinal product or participation in another investigational therapeutic study, at any time during the treatment period and 30 days preceding study entry
8.Life expectancy <12 weeks
9.Unwilling or unable to provide written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with Castration-resistant prostate cancer using Progression Free Survival rate;<br> Secondary Objective: - To determine whether early falls (at two weeks) in Circulating Tumour Cells (CTC) predict for PFS<br> - To assess the changes of PSA (pre and post treatment)<br> - To study PFS and OS<br> - To assess the effect of this schedule on re-induction of hormone sensitivity<br> - To study the quality of life changes<br> ;Primary end point(s): To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with CRPC using Progression Free Survival rate
- Secondary Outcome Measures
Name Time Method