Investigating the effect of a virus-based immunotherapy as a pre-surgical treatment for prostate cancer
- Conditions
- Prostate CancerCancer - Prostate
- Registration Number
- ACTRN12620001286932
- Lead Sponsor
- Royal Melbourne Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
1.Patient has provided written informed consent
2.Patients with histologically confirmed prostate adenocarcinoma
3.Age greater than or equal to 18 years
4.Suitable for radical prostatectomy in the opinion of the treating surgeon, following results of all screening investigations, including PSMA PET/CT scan
5.Disease detectable on MRI
6.Patient has adequate organ function within 7 days prior to registration as defined as:
White blood cell count (WCC) greater than or equal to 2 x 109/L
Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L
Haemoglobin greater than or equal to 90 g/L
Platelet count greater than or equal to 100 x 109/L
Activated partial thromboplastin time (aPTT) less than or equal to 1.5 ULN
International Normalized Ratio (INR) less than or equal to 1.5 ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN unless liver metastases are present, in which case it must be less than or equal to 5 x ULN
Serum sodium 130-150mmol/L
Serum potassium 3.0-5.5mmol/L
Serum Corrected Calcium 2.0-2.9 mmol/L
Serum Creatinine less than or equal to 1.5 ULN or estimated glomerular filtration rate greater than 30mL/min/1.73m2
Oxygen saturation (SaO2) by pulse oximetry greater than 90% at rest
7.For patients who are sexually active with partners of childbearing potential: willing to use double barrier contraception method for at least 6 weeks after each treatment of Pexa-Vec
8.Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations during both the treatment and follow-up phases
1.Prior anti-cancer therapy for prostate cancer
2.High volume metastatic disease on imaging including PSMA PET/CT as defined by
one or more of the following criteria:
a.The presence of visceral metastases
b.greater than or equal to 4 bone lesions, including greater than or equal to 1 beyond the vertebral bodies and pelvis
3.Low-risk prostate cancer as defined by all of the following criteria
a.PSA < 20ng/ml
b.Gleason score 3+4=7 or equal to or less than 6
c.Clinor equal toical stage < T2c
4.Known immunodeficiency due to underlying illness (e.g., human immunodeficiency
virus [HIV] / acquired immune deficiency syndrome [AIDS]) and/or long-term
immune-suppressive medication including high-dose corticosteroids (defined as >10
mg/day prednisone or equivalent)
5.Known myeloproliferative disorders requiring systemic therapy
6.History of severe inflammatory or exfoliative skin condition (e.g. eczema or ectopic
dermatitis) requiring systemic therapy
7.Tumour in location that would potentially result in significant clinical adverse effects if post-treatment tumour swelling were to occur
8.Tumour invading a major vascular structure or other key anatomical structure
9.Severe or unstable cardiovascular disease, including but not limited to significant
coronary artery disease (e.g., myocardial infarction or other coronary artery disease
requiring angioplasty or stenting) or congestive heart failure within the preceding 12
months
10.Inability to suspend treatment with anti-hypertensive medication (including but not
limited to: diuretics, beta-blockers, angiotensin converting enzyme [ACE] inhibitors,
aldosterone antagonists, etc.) for 48 hours prior to and 48 hours after all Pexa-Vec
treatments
11.Use of anti-viral medications
12.Use of anti-platelet, or anti-coagulation medication that cannot be safely suspended
prior to IT injections
13.Medical conditions that place the patient at risk should tachycardia, hypotension or
volume loading occur during or following treatment with Pexa-Vec
14.Experienced a severe systemic reaction or side-effect as a result of a previous
smallpox vaccination
15.Other medical condition or laboratory abnormality or active infection that in the
judgment of the Investigator may increase the risk associated with study participation
or may interfere with interpretation of study results and/or otherwise make the patient
inappropriate for entry into this study
16.Prior malignancy except for cancer from which the patient has been disease-free for 3
years, or the following: adequately treated basal or squamous cell skin cancer, in situ
carcinoma (including cervical, breast and superficial bladder cancer)
17.Prior or planned organ transplant
18.Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be
discontinued within 14 days prior to any Pexa-Vec dose
19.Known active Hepatitis B or Hepatitis C
20.Patients must not receive live vaccines, other than Pexa-Vec, within 30 days of
planned start of Pexa-Vec, during the study, and for a minimum of 15 weeks after the
last dose of Pexa-Vec
21.Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural
effusions
22.Inability to avoid direct physical contact
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method