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Therapeutics in Active Prostate Cancer Surveillance (TAPS02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191680
Recruitment Status : Not yet recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Collaborators:
University of Cambridge
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
This is a phase 3, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Apalutamide Oral Tablet [Erleada] Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial will occur in 2 phases. Following an initial 3-arm pilot phase, a go-no go decision will be made. If successful, the trial will progress and adapt to become a 2-arm trial in the subsequent phase (one treatment arm from the pilot phase will be dropped).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Drug Intervention to Inhibit Cancer Progression in Men on Active Surveillance for Favourable Prognosis Prostate Cancer: A Randomised Trial - Therapeutics in Active Prostate Cancer Surveillance (TAPS02)
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arm Intervention/treatment
Experimental: Apalutamide 6 months
Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
Drug: Apalutamide Oral Tablet [Erleada]
Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Other Name: Erleada

Experimental: Apalutamide 3 months + Placebo 3 months
Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.
Drug: Apalutamide Oral Tablet [Erleada]
Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Other Name: Erleada

Placebo Comparator: Placebo 6 months
Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.
Drug: Placebo
Placebo to match apalutamide




Primary Outcome Measures :
  1. MRI defined tumour volume (Pilot phase) [ Time Frame: 12 months after end of treatment ]
    >50% reduction in tumour volume

  2. Cumulative rate of disease progression (Full Trial) [ Time Frame: 3 years after completion of treatment ]
    Progression defined as tumour classification into a Grade Group 3 and/or T3 stage and/or composite score of ≥CPG3 disease (The Cambridge Prognostic Group classification system, CPG1-CPG5)


Secondary Outcome Measures :
  1. Reported adverse events (Pilot phase) [ Time Frame: 12 months after end of treatment ]
    as per NCI-CTCAE v5.0

  2. Patient-reported outcomes (Pilot phase) [ Time Frame: cumulative until 12 months after end of treatment ]
    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).

  3. Reported adverse events (Full Trial) [ Time Frame: 3 years after completion of treatment ]
    as per NCI-CTCAE v5.0

  4. Patient-reported outcomes (Full Trial) [ Time Frame: cumulative until 3 years after completion of treatment ]
    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).

  5. Cumulative rate of progression to radical treatment (Full Trial) [ Time Frame: 3 years after completion of treatment ]
  6. Patient-reported outcomes (Pilot phase) [ Time Frame: cumulative until 12 months after end of treatment ]
    Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.

  7. Patient-reported outcomes (Full Trial) [ Time Frame: cumulative until 3 years after completion of treatment ]
    Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent.
  • have an Eastern Cooperative Oncology Group (ECOG) status 0-2.
  • have selected active surveillance as a management option.
  • have an mpMRI (multi parametric Magnetic Resonance Imaging) detectable lesion with an M score of ≥ 3 using Likert scale OR PIRADS (Prostate Imaging Reporting and Data System (PIRADS) version 2.1) reporting criteria.
  • have prostate cancer from a combination of image guided targeted + systematic biopsies and MRI lesion and biopsy are concordant for a prostate cancer diagnosis.
  • not anticipated to require bladder outlet surgery during drug treatment or up to 12 months of Follow Up.

Meet all of the following clinical laboratory assessment criteria:

  • haemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomisation.
  • platelet count ≥ 100 x 10^9/L independent of transfusion and/or growth factors within 3 months prior to randomisation.
  • absolute neutrophil count (ANC) ≥ 1350/µL.
  • serum albumin ≥ 3.0 g/dL.
  • glomerular filtration rate (GFR) ≥ 30ml/min AND Serum creatinine ≤ 2 times the ULN concurrent with creatinine clearance ≥ 50mL/min (calculated by Cockcroft and Gault equation).
  • serum potassium ≥3.5 mmol/L.
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN AND Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible).
  • have prostate cancer with any one or more of the following:
  • Cambridge Prognostic Group 2 (Favourable intermediate risk prostate cancer by AUA criteria) OR CPG1 (AUA Low risk) with PSA high density (PSAd>0.15).
  • have a LIKERT or PIRADS 4/5 lesion (individual or combined) of ≥10mm and be at least CPG1 (no PSAd limit).

Exclusion Criteria:

  • Contraindications to apalutamide or its excipients.
  • Pelvic metalwork interfering with MRI prostate interpretation.
  • Any prior use of androgen deprivation therapy or androgen receptor targeting agents (not including 5-alpha reductase inhibitors).
  • Any prior systemic therapy for prostate cancer.
  • Inability for patient to have prostate mpMRI scan.
  • Concurrent CTIMP involvement; participation in an observational study/ studies is acceptable.
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomisation, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing oedema or mass effect).
  • Participant has history/is at risk of falls/fracture.
  • Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomisation. Cardiovascular risk factors should be optimised i.e. hypertension, diabetes, dyslipidaemia.
  • Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP≥90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Gastrointestinal disorder affecting absorption.
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry.
  • Medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes.
  • Strong inhibitors of CYP2C8.
  • Strong inhibitors of CYP3A4.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191680


Contacts
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Contact: Aneta Drozd 01223256364 aneta.drozd@addenbrookes.nhs.uk

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Janssen-Cilag Ltd.
Investigators
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Principal Investigator: Vincent J Gnanapragasam, Prof. Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: Vincent Gnanapragasam, Professor of Urology and Honorary Consultant Urologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05191680    
Other Study ID Numbers: TAPS02
2021-006106-75 ( EudraCT Number )
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust:
active surveillance
prostate cancer
therapeutics in prostate cancer
apalutamide
short term androgen deprivation therapy
androgen receptor inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases