Cancer of the ProstatePhase 2NCT03124433
Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
A Phase 2 study testing Apalutamide in people with Cancer of the Prostate, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Read more about this study
- Who is it for?
- Ages 21 to 75 years, men only
- Conditions the study is for
- Cancer of the Prostate
- 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
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jun 2017to 22 Aug 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 21 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically diagnosed primary adenocarcinoma of the prostate gland
- non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
- no known hypersensitivity to the study drug
- able to swallow study drug as whole tablets
Who cannot join
- presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
- individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
- patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
- renal impairment with serum creatinine more than twice the upper limit of normal
- Other prior malignancy less than or equal to 5 years prior to recruitment
- ECOG performance status 2 or poorer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer
This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.
The primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide
The study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.
Read the detailed description
This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.
Safety will be monitored throughout the study.
- Conditions
- Cancer of the Prostate
- Being tested
- Apalutamide
- Keywords
- prostate cancer, prostatectomy, retropubic, Androgen Receptor Antagonists
- 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
Participants will receive oral apalutamide 240mg daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant apalutamide | Experimental | Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy
This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy
Measured: 24 weeks
Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy
Patients who attain serum PSA levels below 0.03microg/L
Measured: 24 weeks
Secondary outcomes (2)
Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide
Adverse effects as defined by CTCAE criteria grade 3 and above
Measured: 12 weeks
The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy
The level of complications defined by Clavien-Dindo classification
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start20 Jun 2017
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lui Shiong Lee, MBBS,MRCS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124433
- Sponsor's protocol ID
- ARN509 - 2016
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang X, Allen JC, Aslim EJ, Tay KJ, Yuen SPJ, Kanesvaran R, Chua MLK, Chong TW, Ho SSH, Lee LS. Patient-reported outcomes of a phase II neoadjuvant apalutamide (ARN-509) and radical prostatectomy in treatment of intermediate- to high-risk prostate cancer (NEAR) trial. Int J Urol. 2022 Nov;29(11):1322-1330. doi: 10.1111/iju.14994. Epub 2022 Aug 24.
PubMed 36000794Lee LS, Sim AYL, Ong CW, Yang X, Ng CCY, Liu W, Rajasegaran V, Lim AMS, Aslim EJ, Ngo NT, Khor LY, Kanesvaran R, Allen JCJ, Tay KJ, Yuen JSP, Chong TW, Ho SSH, Teh BT, Chua MLK. NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):741-748. doi: 10.1038/s41391-022-00496-8. Epub 2022 Jan 28.
PubMed 35091711
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03124433
- Acronym / sponsor ID
- ARN509 - 2016
- Conditions
- Cancer of the Prostate
- Keywords
- prostate cancer, prostatectomy, retropubic, Androgen Receptor Antagonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 21 Apr 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.
This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.
The primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide
The study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.
Detailed description
This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.
Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant apalutamide | Experimental | Drug: ApalutamideOral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically diagnosed primary adenocarcinoma of the prostate gland
- non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
- no known hypersensitivity to the study drug
- able to swallow study drug as whole tablets
Key exclusion criteria (6 listed)
- presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
- individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
- patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
- renal impairment with serum creatinine more than twice the upper limit of normal
- Other prior malignancy less than or equal to 5 years prior to recruitment
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: ARN509Participants will receive oral apalutamide 240mg daily for 12 weeks | Drug | Neoadjuvant apalutamide |
Primary outcome
Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy
Time frame: 24 weeks
This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy
Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy
Time frame: 24 weeks
Patients who attain serum PSA levels below 0.03microg/L
2 secondary outcomes
Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide
Time frame: 12 weeks
The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy
Time frame: 24 weeks
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 Mar 2020.
- Derived from this study: PubMed 36000794Yang X, Allen JC, Aslim EJ, Tay KJ, Yuen SPJ, Kanesvaran R, Chua MLK, Chong TW, Ho SSH, Lee LS. Patient-reported outcomes of a phase II neoadjuvant apalutamide (ARN-509) and radical prostatectomy in treatment of intermediate- to high-risk prostate cancer (NEAR) trial. Int J Urol. 2022 Nov;29(11):1322-1330. doi: 10.1111/iju.14994. Epub 2022 Aug 24.
- Derived from this study: PubMed 35091711Lee LS, Sim AYL, Ong CW, Yang X, Ng CCY, Liu W, Rajasegaran V, Lim AMS, Aslim EJ, Ngo NT, Khor LY, Kanesvaran R, Allen JCJ, Tay KJ, Yuen JSP, Chong TW, Ho SSH, Teh BT, Chua MLK. NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):741-748. doi: 10.1038/s41391-022-00496-8. Epub 2022 Jan 28.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer of the Prostate
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Lui Shiong Lee, MBBS,MRCS principal investigator
Singapore General Hospital
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 Cancer of the Prostate, run by Singapore General Hospital at 1 site in Singapore.
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 4 inclusion and 6 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 Mar 2020. 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 Singapore. 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?
Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124433, which also lists 2 linked publications.
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 Mar 2020.