Who is sponsoring NCT04049747?

NCT04049747 is sponsored by Imperial College London.

What drugs are being tested in NCT04049747?

Interventions in NCT04049747: Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy], Focal therapy, Focal therapy after Finasteride 5Mg tablets for 12 weeks, Focal therapy after Bicalutamide 50Mg tablets for 12 weeks.

What condition does NCT04049747 study?

NCT04049747 studies Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Adenocarcinoma.

Is NCT04049747 still recruiting?

NCT04049747 is currently completed. Last updated 24 March 2025.

Are results published for NCT04049747?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-24 · How we verify

NCT04049747: IP4-CHRONOS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer

Completed NA Results posted Last updated 24 March 2025

What this trial tests

NA trial testing Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy] in Prostate Cancer in 100 participants. Completed in 20 March 2023.

Timeline

11 December 2019

Primary endpoint
20 March 2023

20 March 2023

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	11 December 2019
Primary completion	20 March 2023
Estimated completion	20 March 2023
Sites	10 locations across United Kingdom

Drugs / interventions tested

Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]
Focal therapy
Focal therapy after Finasteride 5Mg tablets for 12 weeks
Focal therapy after Bicalutamide 50Mg tablets for 12 weeks

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Non-metastatic Prostate Cancer — all drugs for Non-metastatic Prostate Cancer →
Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Imperial College London

Who can join

18 and older, male only, with Prostate Cancer or Non-metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pilot: Acceptance of Randomisation to Allocated Arm Within CHRONOS A & CHRONOS B Primary · 12 months

To assess the acceptance of randomisation to the allocated arm within CHRONOS A \& CHRONOS B separately using rates of compliance, and rates of withdrawal

Group	Value	95% CI
CHRONOS A - Arm 1 (Control)	4
CHRONOS A - Arm 2 (Intervention)	0
CHRONOS B - Arm 3 (Control)	11
CHRONOS B - Arm 4 (Intervention):	10
CHRONOS B - Arm 5 (Intervention)	11
CHRONOS A - Arm 1 (Control)	11
CHRONOS A - Arm 2 (Intervention)	8
CHRONOS B - Arm 3 (Control)	8
CHRONOS B - Arm 4 (Intervention):	9
CHRONOS B - Arm 5 (Intervention)	5
CHRONOS A - Arm 1 (Control)	0
CHRONOS A - Arm 2 (Intervention)	4
CHRONOS B - Arm 3 (Control)	0
CHRONOS B - Arm 4 (Intervention):	0
CHRONOS B - Arm 5 (Intervention)	2
CHRONOS A - Arm 1 (Control)	0
CHRONOS A - Arm 2 (Intervention)	2
CHRONOS B - Arm 3 (Control)	3
CHRONOS B - Arm 4 (Intervention):	1
CHRONOS B - Arm 5 (Intervention)	2

Pilot: Recruitment Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals Primary · 12 months

To estimate the recruitment rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The recruitment rate is defined as number recruited (consented) over total number of patients approached.

Group	Value	95% CI
CHRONOS A - Arm 1 (Control)	8.5	5.1 – 13.1
CHRONOS A - Arm 2 (Intervention)	8.5	5.1 – 13.1
CHRONOS B - Arm 3 (Control)	14.9	9.6 – 21.6
CHRONOS B - Arm 4 (Intervention)	14.2	9 – 20.9
CHRONOS B - Arm 5 (Intervention)	14.2	9 – 20.9

Pilot: Treatment Compliance to CHRONOS - A Primary · 12 months

To determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS A only and corresponding 95% confidence interval. CHRONOS B results provided in a separate table

Group	Value	95% CI
CHRONOS A - Arm 1 (Control)	72.2	46.5 – 90.3
CHRONOS A - Arm 2 (Intervention)	88.9	65.3 – 98.6

Pilot: Treatment Compliance (CHRONOS-B) Primary · 12 months

To determine the treatment compliance of patients to receiving the treatment they have been allocated to through randomisation within CHRONOS B only and corresponding 95% confidence interval CHRONOS A results provided in a separate table

Group	Value	95% CI
CHRONOS B - Arm 3 (Control)	100	84.6 – 100
CHRONOS B - Arm 4 (Intervention):	100	83.9 – 100
CHRONOS B - Arm 5 (Intervention)	100	83.9 – 100

Drug Compliance to CHRONOS-B Only Primary · 12 months

To determine patients drug compliance to allocated IMP treatment within randomisation of CHRONOS-B Arm 4 and Arm 5 only as CHRONOS -B Arm 3 is non-IMP. CHRONOS Arm A is not included as both arms are non-IMP

Returned empty blister packs

Group	Value	95% CI
CHRONOS B - Arm 4 (Intervention):	33.3	14.6 – 57
CHRONOS B - Arm 5 (Intervention)	23.8	8.2 – 47.2

Patients given the IMP

Group	Value	95% CI
CHRONOS B - Arm 4 (Intervention):	100	83.9 – 100
CHRONOS B - Arm 5 (Intervention)	100	83.9 – 100

Pilot: Randomisation Rate to CHRONOS A & CHRONOS B and Their Corresponding 95% Confidence Intervals Primary · 12 months

To estimate the randomisation rate to CHRONOS A \& CHRONOS B and their corresponding 95% confidence intervals The Randomisation rate is defined as number of randomised patients over total number of patients recruited (consented)

Group	Value	95% CI
CHRONOS A - Arm 1 (Control)	48.6	31.9 – 65.6
CHRONOS A - Arm 2 (Intervention)	48.6	31.9 – 65.6
CHRONOS B - Arm 3 (Control)	34.4	22.9 – 47.3
CHRONOS B - Arm 4 (Intervention)	32.8	21.6 – 45.7
CHRONOS B - Arm 5 (Intervention)	32.8	21.6 – 45.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year, 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CHRONOS A - Arm 1 (Control)

Serious: 1/18 (6%)

Deaths: 0/18

CHRONOS A - Arm 2 (Intervention) Focal Therapy Alone

Serious: 1/18 (6%)

Deaths: 0/18

CHRONOS B - Arm 1 (Control) Focal Therapy Alone

Serious: 3/22 (14%)

Deaths: 0/22

CHRONOS B - Arm 2 (Intervention) Neoadjuvant Finasteride 5mg

Serious: 0/21 (0%)

Deaths: 0/21

CHRONOS B - Arm 3 (Intervention) Neoadjuvant Bicalutamide 50mg

Serious: 3/21 (14%)

Deaths: 0/21

Serious adverse events (12 terms)

Reaction	System	CHRONOS A - Arm 1 (Control)	CHRONOS A - Arm 2 (Interve…	CHRONOS B - Arm 1 (Control…	CHRONOS B - Arm 2 (Interve…	CHRONOS B - Arm 3 (Interve…
Common bile duct stones	Renal and urinary disorders	—	—	—	—	—
Iatrogenic scrotal oedema (Primary)	Renal and urinary disorders	—	—	—	—	—
Acute Urinary retention	Renal and urinary disorders	—	—	—	—	—
Paraphimosis	Renal and urinary disorders	—	—	—	—	—
urosepsis	Renal and urinary disorders	—	—	—	—	—
Bacterial Cellulitis and Related Condition	Renal and urinary disorders	—	—	—	—	—
Pleuritic chest pain	Cardiac disorders	—	—	—	—	—
Visible haematuria	Renal and urinary disorders	—	—	—	—	—
Torsades de Pointes	Metabolism and nutrition disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Infection due to common bile duct stones	Gastrointestinal disorders	—	—	—	—	—
Aortic stenosis	Cardiac disorders	—	—	—	—	—

Other adverse events (58 terms — click to expand)

Reaction	System	CHRONOS A - Arm 1 (Control)	CHRONOS A - Arm 2 (Interve…	CHRONOS B - Arm 1 (Control…	CHRONOS B - Arm 2 (Interve…	CHRONOS B - Arm 3 (Interve…
Urinary tract infection	Infections and infestations	—	—	—	—	—
Erectile Dysfunction	Renal and urinary disorders	—	—	—	—	—
Lower Urinary Tract Symptoms	Renal and urinary disorders	—	—	—	—	—
Urinary Retention	Renal and urinary disorders	—	—	—	—	—
Complications of urinary catheter	Infections and infestations	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Visible haematuria	Renal and urinary disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Allergic reaction to Penicillin	Immune system disorders	—	—	—	—	—
Aortic stenosis	Cardiac disorders	—	—	—	—	—
Bacterial Cellulitis and Related Conditions	Infections and infestations	—	—	—	—	—
Blood from urethral meatus when straining	Renal and urinary disorders	—	—	—	—	—
Campylobacter	Infections and infestations	—	—	—	—	—
Chest infection	Infections and infestations	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
COVID	Immune system disorders	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—
Dry ongoing cough, Chest xray clear	General disorders	—	—	—	—	—
Dry Orgasm	Renal and urinary disorders	—	—	—	—	—
Ejaculatory dysfunction	Renal and urinary disorders	—	—	—	—	—
Elective (planned) parathyroidectomy	Renal and urinary disorders	—	—	—	—	—
Epididymo-orchitis	Renal and urinary disorders	—	—	—	—	—
Failed removal of common bile duct stones	Renal and urinary disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Haemtospermia	Renal and urinary disorders	—	—	—	—	—
Head injury	Injury, poisoning and procedural complications	—	—	—	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—	—	—	—
Iatrogenic Scrotal Oedema	Renal and urinary disorders	—	—	—	—	—
Infection following tooth extraction	Infections and infestations	—	—	—	—	—
Knee Replacement	General disorders	—	—	—	—	—
Low urinary flow rate	Renal and urinary disorders	—	—	—	—	—
Nocturia	General disorders	—	—	—	—	—
Painful nipples	General disorders	—	—	—	—	—
Painless swelling and mild bruising of scrotal and penile skin	Renal and urinary disorders	—	—	—	—	—
pancytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Paraphimosis	Renal and urinary disorders	—	—	—	—	—
bladder malignancy	Renal and urinary disorders	—	—	—	—	—
patient required TURP after urosepsis and retention	Renal and urinary disorders	—	—	—	—	—
Penile numbness	Renal and urinary disorders	—	—	—	—	—
Penile tip pain	Renal and urinary disorders	—	—	—	—	—

Most-reported serious reactions: Common bile duct stones, Iatrogenic scrotal oedema (Primary), Acute Urinary retention, Paraphimosis, urosepsis, Bacterial Cellulitis and Related Condition, Pleuritic chest pain, Visible haematuria.

Data from ClinicalTrials.gov NCT04049747 adverse events section.

Sponsor's own description

Men diagnosed with significant cancer confined to the prostate currently undergo radical therapy directed to the whole prostate (radiotherapy or prostatectomy). These provide good cancer control but can cause significant side effects. Focal Therapy involves targeting the cancer alone, whilst leaving healthy prostate gland alone. Case series have shown similar cancer control over 5 years with a much better side effect profile. However, there have been no randomised control trials (RCTs) comparing the success in cancer control and the quality of life in patients that undergo radical therapy vs those that undergo focal therapy. Further, there is a need to assess the use of additional therapies that may improve the cancer control outcomes following focal therapy. By having a trials platform with two RCTs (CHRONOS-A and CHRONOS-B) that reflect best patient and physician preferences/ equipoise, the investigators aim to answer these questions. To improve acceptability, recruitment and compliance, the investigators have an embedded study aimed at reviewing clinician and patient perspectives and trial acceptability. CHRONOS-A will compare radical therapy to focal therapy, whilst CHRONOS-B will compare focal therapy alone to focal therapy with various therapies targeting the testosterone pathway that can shrink the cancer before it is treated. The investigators think this might improve outcomes further for men that definitely want focal therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

High-Intensity Focused Ultrasound: A Review of Mechanisms and Clinical Applications.
Bachu VS, Kedda J, Suk I, Green JJ, et al · · 2021 · cited 166× · PMID 34374945 · DOI 10.1007/s10439-021-02833-9
Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus?
Ong S, Chen K, Grummet J, Yaxley J, et al · · 2023 · cited 34× · PMID 36083229 · DOI 10.1111/bju.15883
Focal ablation therapy presents promising results for selectively localized prostate cancer patients.
Feng D, Li D, Xiao Y, Wu R, et al · · 2023 · cited 22× · PMID 37691892 · DOI 10.21147/j.issn.1000-9604.2023.04.08
Focal therapy for prostate cancer: what is really needed to move from investigational to valid therapeutic alternative?-a narrative review.
Pellegrino A, Cirulli GO, Mazzone E, Barletta F, et al · · 2022 · cited 5× · PMID 35957731 · DOI 10.21037/atm-22-50
A narrative clinical trials review in the realm of focal therapy for localized prostate cancer.
Lazarovich A, Viswanath V, Dahmen AS, Sidana A. · · 2024 · cited 4× · PMID 39697719 · DOI 10.21037/tcr-23-2406
Revisiting Delphi to Create a Basis for the Future of Focal Therapy for Prostate Cancer.
Rodríguez-Sánchez L, Emberton M, de Reijke T, Stricker P, et al · · 2024 · cited 4× · PMID 37853538 · DOI 10.5534/wjmh.230160
High-intensity focused ultrasound strategies for treating prostate cancer.
Wu X, Wu Y, Ng CF, Yee CH, et al · · 2024 · cited 3× · PMID 38727256 · DOI 10.4103/aja20245
Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study.
Day E, Prevost AT, Sydes MR, Reddy D, et al · · 2021 · cited 2× · PMID 34407860 · DOI 10.1186/s13063-021-05509-w

Verify or expand the search:

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Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04049747 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Imperial College London
Last refreshed: 24 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04049747.

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