An open label, Phase II study of vaccination with Survivin peptides emulsified in Montanide ISA 51VG after IMP 321 injection in prostate carcinoma patients with biochemical failure (PROVAX study) - ND

• Conditions: Prostate cancer, biochemical failure after all potentially curative standard local therapies (radiotherapy, brachytherapy and surgery) or biochemical progression while patients have castrated levels of testosterone or after first-line anti hormonal therapy; MedDRA version: 12.1Level: LLTClassification code 10001200Term: Adenocarcinoma of the prostate stage I

• Registration Number: EUCTR2009-017798-39-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-15
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

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

Inclusion Criteria

1.Aged 18 years or older
2.Histological or cytological confirmation of prostate adenocarcinoma
3.Biochemical recurrence after potentially curative standard therapies for localized disease or Biochemical progression while the patient has castrate levels of testosterone (Castration resistant prostate cancer) or patients with progression after first-line anti hormonal treatment
4. Negative bone scan (performed no more than 90 days prior enrollment)
5.HLA A1, A2, A3, A24 or B7 as assessed by HLA Genotyping
6.ECOG Performance status 0 or 1
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

Exclusion Criteria

1.Active malignancy other than prostate cancer
2.Clinical evidence of metastatic disease, local recurrence of pelvic lymph node disease
3.PSA > 10 ng/ml
4.History of past or current autoimmune disease or primary or secondary immunodeficiencies
5.Known hypersensitivity to any component of trial treatment

Study & Design

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