Prostate CancerPhase 2TAPS01NCT03365297
Therapeutics in Active Prostate Cancer Surveillance
A Phase 2 study testing Apalutamide in people with Prostate Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial summary
Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Apalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2018to 25 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given Informed Consent (IC) to participate
- Age 18 or over
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Diagnosed with prostate cancer
- Patient selection of active surveillance as a management option
- mpMRI detectable lesion
Show all 12Show fewer
- Prostate cancer on biopsy from a mpMRI defined lesion
- No contraindications to apalutamide
- Normal full blood count and normal renal and liver function tests
- At least 6 months since initiation of active surveillance and/or last rebiopsy date.
- Low or intermediate risk prostate cancer according to National Institute for Health and Care Excellence (NICE) classification
- M score of ≥ 3 using Prostate Imaging Reporting and Data System (PIRADS) version 2 reporting criteria
Who cannot join
- Contraindications to apalutamide or its excipients
- Concurrent medication that can lower seizure threshold
- Prior localised therapy for prostate cancer
- Any prior use of androgen deprivation therapy or androgen receptor targeting agents
- Any prior systemic therapy for prostate cancer
- Patient unable to have prostate 3T mpMRI scan
- Presence of any pelvic or hip metalwork
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust/Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Targeted Drug Intervention to Inhibit Cancer Progression in Men on Active Surveillance for Prostate Cancer. Therapeutics in Active Prostate Cancer Surveillance (TAPS01)
Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. The trial will also evaluate the tolerability and side effect profile of men on AS using short term apalutamide and patient acceptability as a therapeutic strategy, as well as determining feasibility of a larger prospective randomised trial of apalutamide.
Read the detailed description
The numbers of men diagnosed with prostate cancer in the United Kingdom (UK) and worldwide is increasing. In the UK 46,690 men were diagnosed in 2014 alone and it is estimated this figure will be closer to 70,000 by 2030. A significant proportion of these men will present with organ confined and low or intermediate risk disease. There is increasing recognition that many men with low and intermediate risk prostate cancer do not need immediate radical therapy.
There is sufficient evidence that pharmacological intervention used as short-term therapy in men with low to intermediate-risk disease can inhibit the growth of prostate tumours and delay or remove the need for radical therapy in men managed by active surveillance. Given the irrefutable role of the androgen receptor in prostate cancer pathogenesis it is logical to target this pathway as a method of inhibiting or delaying disease progression.
This window study will be built on the known anti-androgen effects of apalutamide and investigate the efficacy of using it as a short intervention strategy to cause a physiological change in the tumour by reducing its volume. Tumour volume can be measured using the well-established place of mpMRI defined tumour volumes as a surrogate of disease presence and change. The rationale for a short duration treatment is that it will not have the long term debilitating effects of androgen deprivation on general health and prevent the onset of androgen resistance.
It is anticipated that if successful, this approach could be a new therapeutic strategy for these men who otherwise are living and waiting for their disease to progress or not.
- Conditions
- Prostate Cancer
- Being tested
- Apalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Also called ARN509, JNJ-56021927
240mg (4x60mg) oral tablets daily over a max. of 90 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | apalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days. Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Response
Tumour volume downsizing/absence of lesion, as determined by mpMRI
Measured: over a 90 day treatment period
Secondary outcomes (2)
Patient Reported Outcomes
Function and wellbeing using established standardised EQ-5D-5L and EORTC-QLQ30+PR25 module questionnaires
Measured: over 120 days
Adverse Events
tolerability and side effect profile
Measured: over 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start5 Jun 2018
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single centre, single arm open labelled Phase II window study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Vincent J Gnanapragasam, Principal investigator, Cambridge University Hospitals NHS Foundation Trust/University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365297
- Sponsor's protocol ID
- TAPS01
- Other IDs
- 2017-001700-29, 2017
- Acronym
- TAPS01
- Status last verified
- Jun 2018
- First submitted
- 21 Nov 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Drug Intervention to Inhibit Cancer Progression in Men on Active Surveillance for Prostate Cancer. Therapeutics in Active Prostate Cancer Surveillance (TAPS01)
- ClinicalTrials.gov ID
- NCT03365297
- Acronym / sponsor ID
- TAPS01 / TAPS01
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. The trial will also evaluate the tolerability and side effect profile of men on AS using short term apalutamide and patient acceptability as a therapeutic strategy, as well as determining feasibility of a larger prospective randomised trial of apalutamide.
Detailed description
The numbers of men diagnosed with prostate cancer in the United Kingdom (UK) and worldwide is increasing. In the UK 46,690 men were diagnosed in 2014 alone and it is estimated this figure will be closer to 70,000 by 2030. A significant proportion of these men will present with organ confined and low or intermediate risk disease. There is increasing recognition that many men with low and intermediate risk prostate cancer do not need immediate radical therapy.
There is sufficient evidence that pharmacological intervention used as short-term therapy in men with low to intermediate-risk disease can inhibit the growth of prostate tumours and delay or remove the need for radical therapy in men managed by active surveillance. Given the irrefutable role of the androgen receptor in prostate cancer pathogenesis it is logical to target this pathway as a method of inhibiting or delaying disease progression.
This window study will be built on the known anti-androgen effects of apalutamide and investigate the efficacy of using it as a short intervention strategy to cause a physiological change in the tumour by reducing its volume. Tumour volume can be measured using the well-established place of mpMRI defined tumour volumes as a surrogate of disease presence and change. The rationale for a short duration treatment is that it will not have the long term debilitating effects of androgen deprivation on general health and prevent the onset of androgen resistance.
It is anticipated that if successful, this approach could be a new therapeutic strategy for these men who otherwise are living and waiting for their disease to progress or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre, single arm open labelled Phase II window study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Apalutamideapalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Given Informed Consent (IC) to participate
- Age 18 or over
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Diagnosed with prostate cancer
- Patient selection of active surveillance as a management option
Key exclusion criteria (7 listed)
- Contraindications to apalutamide or its excipients
- Concurrent medication that can lower seizure threshold
- Prior localised therapy for prostate cancer
- Any prior use of androgen deprivation therapy or androgen receptor targeting agents
- Any prior systemic therapy for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApalutamideAlso: ARN509, JNJ-56021927240mg (4x60mg) oral tablets daily over a max. of 90 days | Drug | Treatment |
Primary outcome
Physiological Response
Time frame: over a 90 day treatment period
Tumour volume downsizing/absence of lesion, as determined by mpMRI
2 secondary outcomes
Patient Reported Outcomes
Time frame: over 120 days
Adverse Events
Time frame: over 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent J Gnanapragasam principal investigator
Cambridge University Hospitals NHS Foundation Trust/University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apalutamide in people with Prostate Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Response (time frame: over a 90 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.