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    Summary
    EudraCT Number:2021-006674-22
    Sponsor's Protocol Code Number:56021927PCR2046
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2021-006674-22
    A.3Full title of the trial
    AD ASTRA (Androgen Deprivation with Apalutamide and STereotactic RAdiotherapy)
    Prospective institutional phase II study of efficacy and safety of androgen deprivation with apalutamide in high-risk prostate cancer patients treated with extremely hypofractionated stereotactic radiotherapy.
    AD ASTRA (Androgénna Deprivácia s Apalutamidom a STereotaktickou RÁdioterapiou)
    Prospektívna inštitucionálna štúdia fázy II účinnosti a bezpečnosti androgénnej deprivácie s apalutamidom u pacientov s karcinómom prostaty s vysokým rizikom liečených ultra- hypofrakcionovanou stereotaktickou rádioterapiou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AD ASTRA (Androgen Deprivation with Apalutamide and STereotactic RAdiotherapy)
    AD ASTRA (Androgénna Deprivácia s Apalutamidom a STereotaktickou RÁdioterapiou)
    A.3.2Name or abbreviated title of the trial where available
    AD ASTRA
    AD ASTRA
    A.4.1Sponsor's protocol code number56021927PCR2046
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
    B.1.3.4CountrySlovakia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTWMA, s.r.o.
    B.5.2Functional name of contact pointMUDr. Beata Čečetková, PhD.
    B.5.3 Address:
    B.5.3.1Street AddressU Hájovny 901
    B.5.3.2Town/ cityPrůhonice
    B.5.3.3Post code252 43
    B.5.3.4CountryCzechia
    B.5.4Telephone number+420724 004 731
    B.5.6E-mailbeata.cecetkova@twma.cz
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erleada
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen - Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.4EV Substance CodeSUB189031
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Localized or a locally advanced high-risk prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is the assessment of efficacy and safety of the combination of ADT, apalutamide and stereotactic radiotherapy on the localized or locally advanced high-risk prostate cancer. Efficacy assessment is determined by the biochemical control rate after 5 years, and biochemical progression is defined according to RTOG – ASTRO Phoenix consensus criteria (a rise by 2 ng/mL or more above the nadir PSA with the date of failure determined "at call"). Safety assessment is determined by the rate of clinically significant G2 and G3 gastrointestinal and genitourinary toxicity.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the assessment of patient´s quality of life using the validated questionnaires, and the assessment of metastasis free survival based on 68Ga PSMA PET/CT. Time to distant metastasis is defined as the time from enrollment to the date of the first occurrence of bone or soft tissue distant metastasis on 68Ga PSMA PET/CT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be a man in the age of 18 – 79 years
    2. Each subject must sign an informed consent form (ICF) indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
    3. Indicated and planned to receive primary RT for prostate cancer.
    4. Histologically confirmed adenocarcinoma of an intact prostate and one of the following risk factors for EUA high-risk localized or locally prostate cancer (see Attachment 1) 14 at diagnosis:
    • Localized high-risk prostate cancer: PSA >20 ng/ml or GS >7 (ISUP grade 4/5) or cT2c
    • Locally advanced high-risk prostate cancer: cT3 – 4 or cN+, any PSA, any ISUP grade
    5. Modified Charlson comorbidity index (CCI) ≤4 (Attachment 2)
    6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade 0 or 1 (Attachment 2)
    7. Adequate organ function determined by the following local laboratory values:
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within normal limits (WNL)
    • Serum creatinine <133 umol/l
    • Thrombocytes ≥140x109/l
    • Hemoglobin ≥120 g/l (no transfusion is allowed within 3 months prior to enrollment)
    8. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed during the Treatment Phase and for 3 months following the last dose of study drug.
    9. Be able to swallow whole study drug tablets, undergo prostate MR, prostate seeds implantation and prostate radiotherapy in supine position.
    E.4Principal exclusion criteria
    1. Presence of distant metastasis on conventional imaging or 68Ga PSMA/PET (clinical stage M1). Isolated pelvic nodal disease below the iliac vessels bifurcation (clinical stage N1) is not an exclusion.
    2. Prior treatment with LHRH agonist/antagonist analogue or anti-androgen or both for >3 months prior to enrollment.
    3. Bilateral orchiectomy
    4. History of pelvic radiation
    5. Prior systemic (e.g., chemotherapy) or local (e.g., radical prostatectomy, cryotherapy) treatment for prostate cancer.
    6. Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer.
    7. Prior treatment with systemic glucocorticoids ≤4 weeks prior to enrollment or subject expected to require long-term use of corticosteroids during the study.
    8. Use of first-generation antiandrogen (e.g., bicalutamide) ≤4 weeks prior to enrollment.
    9. Use of 5-α reductase inhibitors (e.g., dutasteride, finasteride) ≤4 weeks prior to enrollment.
    10. Use of any investigational agent ≤4 weeks prior to enrollment.
    11. Current chronic use of opioid analgesics, for ≥3 weeks for oral or ≥7 days for non-oral formulations.
    12. Major surgery ≤4 weeks prior to enrollment
    13. History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to enrollment; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
    14. Current or prior treatment with anti-epileptic medications for the treatment of seizures.
    15. Gastrointestinal conditions affecting absorption.
    16. Known or suspected contraindications or hypersensitivity to apalutamide or LHRH agonists/antagonist or any of the components of the formulations.
    17. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject.
    E.5 End points
    E.5.1Primary end point(s)
    5 –year biochemical control rate defined as a percentage of surviving patients without biochemical progression after 5 years since the treatment start (assessed by Kaplan-Meier estimate)
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 years
    E.5.2Secondary end point(s)
    Major secondary endpoint:
    Metastasis free survival based on PSMA PET/CT (assessed by Kaplan-Meier estimate). Time to distant metastasis is defined as the time from enrollment to the date of the first occurrence of radiographic or pathological bone or soft tissue distant metastasis 68Ga PSMA PET/CT

    Other secondary endpoints:
    5 –year biochemical control rate with PSA <0.2 ng/mL
    5 –year prostate cancer specific survival
    5 – year overall survival. OS is defined as the time from enrollment to date of death from any cause.
    Incidence of acute and late side effects and complications associated with radiotherapy and systemic treatment evaluated by Common Terminology Criteria of Adverse Event (CTC AE) and Patient Reported Outcomes (PRO)
    Effect of the planned interventions on QoL (I-PSS and EPIC-26, FACT-P, change from the baseline for the five-level EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Post treatment follow-up 5 years
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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