A PHASE IIB TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF ONY-P VACCINES IN THE MANAGEMENT OF PROSTATE CANCER WITHOUT DETECTABLE METASTASES FOLLOWING INITIAL ESCAPE FROM HORMONE TREATMENT - THE TREATMENT OF ADVANCED PROSTATE CANCER USING DISABLED CANCER CELLS AS VACCINES
- Conditions
- Prostate cancer without detectable metastases following initial escape from hormone treatment
- Registration Number
- EUCTR2006-001619-31-GB
- Lead Sponsor
- Onyvax Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 150
A patient is eligible for the trial if all of the following inclusion criteria are met:
A patient of any age with documented histologically confirmed prostate cancer and a life expectancy of at least six months.
A patient previously treated with any licensed hormone therapy (except oestrogens) and/or orchidectomy. The patient must continue to receive the same hormone therapy at the same dose throughout the trial.
Patients who have received the following licensed treatments and/or orchidectomy must have documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormonal treatment: LHRH agonists, combined androgen blockade. Patients who have been treated with androgen monotherapy are not required to have documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormaonal treatment, however, testosterone levels must be recorded.
A patient with a documented hormone break through prostate cancer indicated by a rise in serum PSA on at least 2 successive occasions separated by at least 4 weeks while continuing to receive hormone therapy prior to Week-4.
A patient with a serum PSA level of at least 2ng/ml at Week –4 that is higher than at least one of the two previous serum PSA levels all separated by at least 4 weeks between the tests.
A patient with no radiological evidence of bone or soft tissue metastases in the four week period prior to randomisation.
A patient with a haemoglobin level of 10g/dL or more at Week -2
A patient with a white cell count of 2500 per cu cm or more at Week –2
A patient with no two liver enzymes more than 5 times the ULN at Week-2
A patient must have the ability to read and understand the patient information sheet and to give written informed consent.
A patient must be able and willing to attend the Hospital for all trial treatments and assessments for the duration of the trial.
A patient must agree to be followed up irrespective of whether they left the trial early or they are discontinued from the trial or they completed the trial.
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
A patient will not be eligible for the trial if any of the following criteria are met:
A patient who has no documented histological confirmation of prostate cancer
A patient with clinical or radiological evidence of metastatic prostate disease.
A patient previously treated with the following licensed treatments and/or orchidectomy with no documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormonal treatment: LHRH agonists, combined androgen blockade. Patients receiving oestrogens for treatment of their prostate cancer are not eligible for the study.
A patient who has a PSA level < 2ng/ml at Week -2.
A patient who has had a previous malignancy or has an active malignancy other than prostrate cancer with the exception of basal cell carcinoma of the skin.
A patient who has a life expectancy of less than 6 months.
A patient who has a known immunodeficiency.
A patient who is receiving any therapy with a known immunosuppressive activity.
A patient who has taken oral/inhaled/ parental corticosteroids up to 1 month prior to screening or is proposing to take or likely to take during the trial.
A patient who has taken oestrogens or ketoconazole up to 1 month prior to screening or is likely to take during the trial.
A patient who has been treated with cytotoxic therapy up to 3 months prior to screening into the trial.
A patient who has been treated with any investigational medicinal product up to 3 months prior to screening or during the trial.
A patient who has a known hypersensitivity to the one or more components of the trial medications.
A patient who has had previous exposure to a prostate cancer vaccine.
A patient who is unable or unwilling to attend all visits and assessments.
A patient who is unable to understand the patient information sheet or is unable to give written informed consent.
A patient with an active tuberculosis infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method