Cancer of ProstateNCT05653063
ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
An observational study of Cancer of Prostate and Cancer Head Neck, run by University College, London at 6 sites in 4 countries.
Trial summary
The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Prostate, Cancer Head Neck, Cancer Cervix
- What is being tested?
- A web-based artificial intelligence (AI) auto-planning tool
- How many people
- 1,029 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 7 Dec 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for radiotherapy for head and neck, cervical or prostate cancer.
Who may be able to join
- Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.
- Mental capacity to understand and consent to participate in the study.
- Patients aged ≥18years.
Who cannot join
- Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.
- Patients receiving palliative radiotherapy
- Patients aged < 18years.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
South Africa2 sites
Groote Schuur Hospital
Cape Town
Tygerberg Hospital
Stellenbosch
About this study
The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.
The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.
- Conditions
- Cancer of Prostate, Cancer Head Neck, Cancer Cervix
- Being tested
- A web-based artificial intelligence (AI) auto-planning tool
- Medical subject headings
- Prostatic Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A web-based artificial intelligence (AI) auto-planning toolOther
The CT scan taken at the time of treatment planning is uploaded to a web server called the Radiotherapy planning assistant which automates the contouring of target organs and areas of high-risk disease as well as defining the size, shape and number of radiotherapy beams to treat the cancer. The final plan is downloaded to the local treatment planning system where the doses are recalculated and clinical peer review is undertaken before the plan can be used clinically.
In this study patients will not be treated with the AI tool but the manual plan created by the local teams.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability
Measured: Prior to first treatment
Secondary outcomes (2)
comparison of time and human resource requirements between producing automated radiotherapy treatment plans using artificial intelligence and producing treatment plans using the standard manual pathway
Measured: radiotherapy plan preparation process pre treatment
Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway
Measured: radiotherapy treatment plan preparation process and treatment interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start7 Dec 2023
- Primary completion16 Jan 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of ProstateStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Rising Tide Foundation, Medical Research Council, Tata Memorial Hospital, Tata Memorial Centre, University of Stellenbosch, King Hussein Cancer Center, University of Malaya, University Ghent, M.D. Anderson Cancer Center, Mount Vernon Cancer Centre at Mount Vernon Hospital, University of Cape Town, National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653063
- Sponsor's protocol ID
- ARCHERY
- Other IDs
- 1U01CA269143-01, 10678756
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aggarwal A, Court LE, Hoskin P, Jacques I, Kroiss M, Laskar S, Lievens Y, Mallick I, Abdul Malik R, Miles E, Mohamad I, Murphy C, Nankivell M, Parkes J, Parmar M, Roach C, Simonds H, Torode J, Vanderstraeten B, Langley R. ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer - study protocol. BMJ Open. 2023 Dec 7;13(12):e077253. doi: 10.1136/bmjopen-2023-077253.
PubMed 38149419
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
- ClinicalTrials.gov ID
- NCT05653063
- Acronym / sponsor ID
- ARCHERY
- Conditions
- Cancer of Prostate, Cancer Head Neck, Cancer Cervix
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Rising Tide Foundation, Medical Research Council, Tata Memorial Hospital, Tata Memorial Centre, University of Stellenbosch, King Hussein Cancer Center, University of Malaya, University Ghent, M.D. Anderson Cancer Center, Mount Vernon Cancer Centre at Mount Vernon Hospital, University of Cape Town, National Cancer Institute (NCI)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Dec 2022 (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.
The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.
The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for radiotherapy for head and neck, cervical or prostate cancer.
Key inclusion criteria (5 listed)
- Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.
- Mental capacity to understand and consent to participate in the study.
- Patients aged ≥18years.
Key exclusion criteria (3 listed)
- Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.
- Patients receiving palliative radiotherapy
- Patients aged < 18years.
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 |
|---|---|---|
| A web-based artificial intelligence (AI) auto-planning toolThe CT scan taken at the time of treatment planning is uploaded to a web server called the Radiotherapy planning assistant which automates the contouring of target organs and areas of high-risk disease as well as defining the size, shape and number of radiotherapy beams to treat the cancer. The final plan is downloaded to the local treatment planning system where the doses are recalculated and clinical peer review is undertaken before the plan can be used clinically. In this study patients will not be treated with the AI tool but the manual plan created by the local teams. | Other | – |
Primary outcome
Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability
Time frame: Prior to first treatment
2 secondary outcomes
comparison of time and human resource requirements between producing automated radiotherapy treatment plans using artificial intelligence and producing treatment plans using the standard manual pathway
Time frame: radiotherapy plan preparation process pre treatment
Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway
Time frame: radiotherapy treatment plan preparation process and treatment interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 38149419Aggarwal A, Court LE, Hoskin P, Jacques I, Kroiss M, Laskar S, Lievens Y, Mallick I, Abdul Malik R, Miles E, Mohamad I, Murphy C, Nankivell M, Parkes J, Parmar M, Roach C, Simonds H, Torode J, Vanderstraeten B, Langley R. ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer - study protocol. BMJ Open. 2023 Dec 7;13(12):e077253. doi: 10.1136/bmjopen-2023-077253.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Prostate and Cancer Head Neck, run by University College, London at 6 sites in 4 countries.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India, South Africa, Jordan, Malaysia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability (time frame: Prior to first treatment). 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 NCT05653063, which also lists 1 linked publication.
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 22 Jul 2026.