Trial investigating hormone injections, external beam radiotherapy and intravenous radionuclide injection in patients with advanced prostate cancer.

• Conditions: Metastatic castration sensitive prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000273-39-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent obtained prior to any study-related procedures
2.Histologically confirmed prostate cancer stage T1-4 N0-1, M1b
3.Patients with =3 bone metastases showing uptake at bone scintigraphy
4.WHO performance status 0 or 1.
5.Life expectancy of at least 12 months.
6.Age = 18years.
7.Absolute neutrophil count (ANC) = 1.5 x109/L
8.Platelet count = 100 x109/L
9.Hemoglobin =10.0 g/dL (100 g/L; 6.2 mmol/L)
10.Total bilirubin level = 1.5 x institutional upper limit of normal (ULN)
11.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
12.Creatinine = 1.5 x ULN
13.Albumin > 25 g/L
14.Patients, even if surgically sterilized (i.e. status post-vasectomy), who:
-will abstain from intercourse
-or must agree to use barrier contraception during and for 6 months after discontinuation of study treatment. If patient impregnates a woman while on treatment or within 3 months of discontinuing treatment, he should inform his treating physician immediately.
15.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
16.Willing and able to comply with the protocol, including follow-up visits and examinations
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Active uncontrolled bacterial, viral or fungal infection.
2.History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin.
3.History of organ allografts requiring immunosuppressive therapy.
4.Serious uncontrolled concomitant disease.
5.Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
6.Received previous radiotherapy to > 25% of bone marrow, including hemibody radiation
7.Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases
8.Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
9.Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
10.Any other serious illness or medical condition, such as but not limited to:
i)Any infection = National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
ii)Cardiac failure New York Heart Association (NYHA) III or IV
iii)Crohn’s disease or ulcerative colitis
iv)Bone marrow dysplasia
v)Faecal incontinence
vi)History of diverticulitis
11.Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
12.Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study entry or during the study]

Study & Design

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