Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT00629057
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent
* Men, 18 - 75 years of age
* Documented prostate cancer with a rising PSA post androgen suppression or blockade therapy
* Chemotherapy naïve
* ECOG Performance Score of 0,1, or 2
* Life expectancy ≥ 1 year
* No significant cardiac, bone marrow, hepatic, or renal dysfunction; or coagulopathy (defined as no AE ≥ Grade 3 according to NCI CTCAE v 3.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may be eligible for inclusion provided an exemption is granted by the study Medical Monitor prior to enrollment.
* A negative virology screen for HIV, hepatitis B surface antigen, and hepatitis C
Exclusion Criteria:
* Metastatic disease
* Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
* History of prior malignancies other than prostate cancer within the past 5 years, excluding basal or squamous cell carcinoma of the skin
* Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
* Chronic administration (defined as 5 or more days of consecutive use) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-PRO. Use of inhaled steroids, nasal sprays, eye drops and topical creams for small body areas is allowed.
* History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement hormones are not excluded.
* Prior solid organ or hematopoietic allogenic transplant(s)
* Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN®-PRO
* Prior "vaccine" therapy for prostate cancer at any time
* Vaccination: Live (attenuated) vaccine (e.g., FluMist®). Vaccination with a live vaccine within 28 days of the first planned dose of MVA-BN®-PRO, or plans to receive a live vaccine within 28 days after the last dose of MVA-BN®-PRO is not allowed
* Vaccination: Killed (inactivated) vaccine (e.g., PneumoVax®). Vaccination with a killed vaccine within 14 days of the first planned dose of MVA-BN®-PRO, or plans to receive a killed vaccine within 14 days after the last dose of MVA-BN®-PRO is not allowed.
* Radiation therapy within 28 days of the first planned dose of MVA-BN®-PRO or plans for radiation therapy during treatment or re-treatment. Prior to initiating palliative radiation during the (re)treatment phase of the study, the Sponsor's medical monitor or designee must be notified.
* Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
* Study personnel
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00629057
Study Brief:
Protocol Section:
NCT00629057