A study to assess effectiveness and safety of a drug RV001V in Men with Biochemical Failure following Curatively Intended Therapy for Localized Prostate Cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 180

Inclusion Criteria

1. Men aged 18 and above with an earlier histologic diagnosis of prostatic adenocarcinoma.
2. Able to understand the study procedures and willing to provide IC.
3. Able and willing to comply with study requirements and complete all visits.
4. Biochemical recurrence (BCR) in compliance with the following 3 conditions:
- after having finished last definitive treatment (including those who have received RP/RT
followed by any modality of salvage therapy),
- no distant metastasis by standard CT imaging with bone scintigraphy or a normal PETCT
and
- no locoregional recurrence (including lymph nodes). Locoregional recurrence will be assessed by multi-parametric magnetic resonance imaging (MRI) in all patients treated
with curative RT and should be confirmed with image guided prostatic gland biopsy in
case of suspicious lesions. Any prostatic biopsy performed should be negative.
5. Prior definitive treatment with RP or RT. In case the patient was subjected to a RP, all the
following will apply:
a. PSA =0.2 ng/mL,
b. PSA Doubling Time (PSADT)a >3 months and <12 months,
c. History of Gleason 7 (4 + 3) or higher.
Conversely, if the patient was treated with definitive RT and not prior RP, all the following
will apply:
a. PSA >nadira + 2 ng/mL,
b. PSADTa >3 months and <12 months,
c. History of Gleason score of 7 (4 + 3) or higher.
6. Eastern Cooperative Oncology Group (ECOG) performance status =2.
7. Laboratory values obtained =30 days prior to first vaccination
a. Hemoglobin =5.6 mmol/L (90 g/L)
b. Absolute granulocyte count =1.5 x 109 /L.
c. Platelets =100 x 109 /L.
d. Total bilirubin =1.5 x upper limit of normal (ULN).
e. Creatinine =1.5 x ULN.
f. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline
phosphatase (ALP) =2.5 x ULN.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Patients who are receiving androgen-deprivation therapy (ADT) or considered a candidate
for immediate ADT or are candidate to any local therapy according to applicable clinical
guidelines or judged by the investigator.
2. Patients who have received prior ADT are not eligible with the exception of those that
received ADT =36 months in duration and =9 months before randomization and
administered only in the neoadjuvant/adjuvant setting.
3. Patient is planned for salvage therapy.
4. Castrate level of serum testosterone <50 ng/dL at screening.
5. PSA >10 ng/mL.
6. Small-cell, signet cell and neuroendocrine variants of adenocarcinomas.
7. An active malignancy likely to interfere with protocol treatment or FU.
8. Patients who have undergone major surgery or have had major bleeding within the last
month prior to the first vaccination.
9. Prior treatment with any therapeutic cancer vaccine(s).
10. Participants with a condition requiring systemic treatment with either corticosteroids (>10
mg daily prednisone equivalent) or other immunosuppressive medications within 14 days
of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses >10
mg daily prednisone equivalent, are permitted in the absence of active autoimmune
disease.
11. History of alcohol or substance abuse within the last 5 years.
12. Patients receiving any investigational drug(s) or treatment within 30 days prior to
inclusion in this trial.
13. History of significant autoimmune disease such as Inflammatory Bowel Disease, Systemic
Lupus Erythematosus, Ankylosing Spondylitis, Scleroderma, Multiple Sclerosis.
14. Severe medical conditions, such as but not limited to severe asthma/chronic obstructive
pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly
regulated insulin dependent diabetes, any significant organ damage as judged by the
Investigator.
15. Other medications, conditions or laboratory results that in the Investigator's opinion would
contraindicate study participation for safety reasons or interfere with the interpretation of
study results.
16. History of known allergy/hypersensitivity to any component of the study drug (such as
Montanide ISA 51), or intolerance to SC injection.
17. Patients with a prior solid organ / stem cell transplantation
18. Patients with known acquired immunodeficiency disorder (AIDS) or
any inherited immunodeficiency disorder

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

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