A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy - VIABLE

Phase 1

• Conditions: metastatic castrate-resistant prostate cancer; MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-002814-38-IT
• Lead Sponsor: SOTIO a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-10
• Study Completion: 2020-01-28
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1182

Inclusion Criteria

1.Male 18 years and older.
2.Histologically or cytologically confirmed prostate adenocarcinoma.
3.Presence of skeletal or soft-tissue/visceral/nodal metastasis according to one of the following criteria:
-Confirmed pathological fracture related to the disease.
-Confirmation of bone and/or soft-tissue and/or visceral metastases through MRI, scintigraphy, PET or CT scan (confirmation by independent review facility (IRF) required)
-Positive pathology report of metastatic lesion.
4.Disease progression despite androgen deprivation therapy (ADT) as indicated by:
-PSA increase by at least 2 ng/ml between two assessments performed at least 14-days apart from each other with the absolute value =5ng/ml and = 50% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed;
OR
-Progression of measurable lymph nodes (= 15mm) or visceral lesion measurable per RECIST v1.1 criteria;
OR
-Two or more new lesions appearing on bone scan/imaging compared with a prior scan (confirmation by IRF required).
5.Maintenance of castrate conditions: Patients, who have not had a surgical orchiectomy, must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to reach levels of serum testosterone of =1.7nmol/l (50ng/dl). The duration of the castration period must be at least 4 months prior to inclusion of the patient into the study.
6.Laboratory criteria:
-White blood cells greater than 4,000/mm3 (4.0 x109/L).
-Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
-Hemoglobin of at least 9g/dL (100g/L).
-Platelet count of at least 100,000/mm3 (100 x109/L).
-Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted).
-Serum alanine aminotransferase and aspartate aminotransferase, and creatinine <1.5 times the ULN.
-Blood Urea Nitrogen <2.0 times the ULN.
7.Life expectancy of at least 6 months based on Investigators judgment.
8.Eastern Cooperative Oncology group (ECOG) Performance status 0-2.
9.At least 4 weeks after surgery or radiotherapy.
10.A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy.
11.No radiopharmaceutical within 8 weeks prior to screening.
12.Recovery from primary local surgical treatment, radiotherapy or orchiectomy.
13.Signed informed consent including patient’s ability to comprehend its contents

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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 670

Exclusion Criteria

1. Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
2. Current symptomatic cord compression requiring surgery or radiation therapy.
3. Prior chemotherapy for prostate cancer
4. Patient co-morbidities:
- Patients who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
- HIV positive, HTLV positive.
- Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis.
- Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
- Clinically significant cardiovascular disease including:
- symptomatic congestive heart failure.
- unstable angina pectoris.
- serious cardiac arrhythmia requiring medication.
- uncontrolled hypertension.
- myocardial infarct or ventricular arrhythmia or stroke within a 6 month period prior to inclusion, ejection fraction EF <40% or serious cardiac conduction system disorders, if a pacemaker is not present.
- Pleural and pericardial effusion of any CTCAE grade.
- Peripheral neuropathy having a CTCAE =Grade 2.
- History of malignant disease (with the exception of non-melanoma skin tumours) in the preceding five years.
- Active autoimmune disease requiring treatment.
- History of severe forms of primary immune deficiencies.
- History or anaphylaxis or other serious reaction following vaccination.
- Known hypersensitivity to any constituent in the DCVAC/PCa or placebo product
- Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial.
5. Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months.
6. Systemic immunosuppressive therapy for any reason.
7. Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumour-focused treatment performed on the day of screening or within previous four weeks (except for GnRH/LHRH agonists or antagonists), due to possible anti-androgen withdrawal response. (This criterion does not apply for subjects, who have never responded to anti-androgen treatment).
8. Refusal to sign the informed consent.
9. Participation in a clinical trial using experimental therapy within the last 4 weeks

Study & Design

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