A Phase 2 interventional study of Apalutamide in Prostate Cancer, sponsored by CCTU- Cancer Theme. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by CCTU- Cancer Theme · Phase 2, Interventional, and Treatment
Among 70 studies testing apalutamide in Prostatic Neoplasms — 14 open to participants now, 36 under way, 12 of them phase 3. apalutamide · Prostatic Neoplasms.
Among the 70 studies testing apalutamide in Prostatic Neoplasms, this one is the 60th largest by enrollment, is one of 8 that started in 2018, is one of 37 in phase 2, and was the 31st registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 11 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →14 of the 70 studies testing apalutamide in Prostatic Neoplasms are open now, in 11 countries. Each count lists the studies.
apalutamide: first FDA approval 2018 (ERLEADA), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →70 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 8 started in 2018.
Median enrollment 81 across the 70 interventional studies. Of the 29 that completed or were terminated, 16 (55%) have results posted.
20 of 70 have an industry lead sponsor. The 10 most frequent:
CCTU- Cancer Theme is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
CCTU- Cancer Theme has 1 study filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
10 of the studies testing apalutamide in Prostatic Neoplasms that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04134260Phase 3NRG OncologyTesting the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial | 2026-11-01 |
| NCT03903835Phase 3Karolinska InstitutetProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | 2026-12 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT02531516Phase 3Aragon Pharmaceuticals, Inc.An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | 2027-03-01 |
| NCT06274047Phase 3M.D. Anderson Cancer CenterPROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. | 2027-06-30 |
Among the 70 studies testing apalutamide in Prostatic Neoplasms, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
apalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days.
Drug: Apalutamide
240mg (4x60mg) oral tablets daily over a max. of 90 days
Also known as: ARN509, JNJ-56021927
Physiological Response
Tumour volume downsizing/absence of lesion, as determined by mpMRI
Time frame: over a 90 day treatment period
Patient Reported Outcomes
Function and wellbeing using established standardised EQ-5D-5L and EORTC-QLQ30+PR25 module questionnaires
Time frame: over 120 days
Adverse Events
tolerability and side effect profile
Time frame: over 120 days
Patient acceptability
number of men approached versus recruited
Time frame: over an estimated 1 year recruitment period
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apalutamide
CCTU- Cancer Theme