A comparison of pelvic extended nodal irradiation and stereotactic body radiotherapy for patients with recurrent prostate cancer
| ISRCTN | ISRCTN11089334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11089334 |
| IRAS number | 327827 |
| Secondary identifying numbers | CPMS 62335, CRCPSC-Jul23/100003 |
- Submission date
- 11/06/2024
- Registration date
- 23/09/2024
- Last edited
- 17/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Prostate cancer can come back after previous treatment with surgery or radiotherapy in glands (known as lymph nodes) in the pelvis, which is what happened to you. When this happens, there are different treatments that could be used for your cancer, but we do not know for certain which treatment is best. The POINTER-PC study is trying to work this out.
Who can participate?
All participants approached about this study have prostate cancer which has come back in lymph glands in their pelvis.
What does the study involve?
Two different types of radiotherapy could be used. The gland(s) could be treated with focused radiotherapy given in a small number of treatments (5 treatments), which is called stereotactic body radiotherapy (SBRT). Or, both the surrounding pelvis as well as the gland(s) known to be cancerous could be treated with radiotherapy. This is known as pelvis radiotherapy.
What are the possible benefits and risks of participating?
This study will compare pelvis radiotherapy with SBRT to see which is better at stopping the cancer from coming back again. Pelvis radiotherapy is usually given in 20 treatments, but it could be shortened to give it in 5 treatments instead. In the study, we will also check if pelvis radiotherapy can be safely given in 5 treatments instead of 20 treatments. Pelvis radiotherapy might be better than SBRT at stopping the cancer coming back again in the pelvis or in another part of the body. SBRT and pelvis radiotherapy in either 5 or 20 treatments can have side effects. Hormone therapies and chemotherapy also carry a risk of side effects.
Where is the study run from?
The Clinical Trials Research Unit at the University of Leeds (UK)
When is the study starting and how long is it expected to run for?
October 2023 to November 2031
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
The POINTER-PC trial team at POINTERPC@leeds.ac.uk
Contact information
Dr Ann Henry
Principal Investigator
Principal Investigator
Department of Clinical Oncology, St James’s University, Beckett St
Leeds
LS9 7TF
United Kingdom
| A.Henry@leeds.ac.uk |
Dr Samantha Noutch
Public, Scientific
Public, Scientific
Leeds Institute of Clinical Trials Research (LICTR), Level 10, Worsley Building, Clarendon Way, University of Leeds
Leeds
LS2 9NL
United Kingdom
| pointerpc@leeds.ac.uk |
Study information
| Study design | Interventional; Design type: Treatment, Radiotherapy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) |
| Study acronym | POINTER-PC |
| Study hypothesis | Objectives: 1. To compare ENI (ENI-20 and ENI-5) with SBRT for the endpoint of Metastatic free survival. 2. To compare ENI-5 with ENI-20 for the endpoint of patient reported outcome measure (PROM)-assessed late bowel toxicity at 3 years. |
| Ethics approval(s) |
Approved 22/05/2024, East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 20 7104 8096; cambsandherts.rec@hra.nhs.uk), ref: 24/EE/0099 |
| Condition | Prostate cancer |
| Intervention | All participants will receive 12 months of hormone therapy, Androgen Deprivation Therapy (ADT), starting either on the first day of radiotherapy or up to one month before radiotherapy starts. A computer-generated minimisation program that incorporates a random element will be used to ensure the treatment groups are well-balanced for the following factors: Number of pelvic nodal recurrences The type of PET-CT at diagnosis of recurrence Whether the participant is planned for systemic anticancer therapy in addition to ADT (docetaxel/second-generation androgen receptor antagonist or androgen biosynthesis inhibitor) versus none Randomisation will be performed centrally using the CTRU automated 24-hour randomisation system. Following confirmation of written informed consent and eligibility, participants will be randomised to receive either stereotactic body radiotherapy, pelvis radiotherapy in 5 fractions, or pelvis radiotherapy in 20 fractions on a 2:1:1 basis, respectively. Prior to treatment: Participants will be assessed for their toxicity levels before treatment begins. They will also be required to complete two questionnaires to assess their status and quality of life. Samples for translational research purposes, including blood and tissue samples, will be collected at this time. Consent for blood samples is optional and will be confirmed with the CTRU. Blood samples will be taken at three time points: prior to treatment, upon completion of treatment, and 3 months after radiotherapy. Consent for providing tissue blocks is mandatory, and participants must agree to the collection and sending of tissue blocks to external labs to participate in the study. One FFPE original biopsy or prostatectomy specimen tissue block will be collected at baseline. On treatment: Depending on randomisation, participants will receive either stereotactic body radiotherapy or pelvis radiotherapy in 5 or 20 fractions. Stereotactic body radiotherapy: 30-40 Gy in 5 fractions delivered on alternate days over 2 weeks, targeting the involved nodes. Pelvis radiotherapy in 5 fractions: 25 Gy in 5 fractions plus a simultaneous integrated boost of 30-40 Gy, delivered on alternate days over 2 weeks, targeting the pelvic nodal area. Pelvis radiotherapy in 20 fractions: 44 Gy in 20 fractions plus a simultaneous integrated boost of 54 Gy to macroscopically involved node(s), delivered daily over 4 weeks, targeting the pelvic nodal area. Treatments will be delivered using intensity-modulated RT (IMRT) with daily online image guidance. Additional systemic anticancer therapies (docetaxel/second-generation androgen receptor antagonist or androgen biosynthesis inhibitor) will be allowed post-radiotherapy. The radiotherapy will be delivered Monday to Friday for either 2 or 4 weeks, depending on the treatment. End of treatment: Participants will be assessed for toxicity at the end of treatment, and a clinical assessment will be performed. Optional translational blood samples will also be taken at this time. Follow-up assessments: Follow-up visits will take place 2 weeks, 6 weeks, 3, 6, 12, 18, 24, 30, and 36 months after the conclusion of radiotherapy. These visits may be conducted in person or over the phone. For phone visits, the participant’s GP will need to perform a PSA blood test and, if consented to, collect a blood sample before the appointment. Reminders for completing the quality-of-life questionnaires will be sent 2 weeks and 4 weeks after the initial link is sent, if the questionnaire has not been completed. Data collection will include: A clinical assessment at every follow-up visit Toxicity assessments at 2 weeks, 6 weeks, 3, 6, 12, 18, 24, 30, and 36 months Health-related quality of life questionnaires at 2 weeks, 3, 6, 12, 24, and 36 months (reminders will be sent as needed) Optional translational blood samples at 3 months PSA blood tests at 6 weeks, 3, 6, 12, 18, 24, 30, and 36 months (standard care) Data analysis: The statistical analysis will be conducted by CTRU statisticians. A detailed statistical analysis plan will be written before any analysis is undertaken, following CTRU standard operating procedures. The primary endpoint analysis will take place once the final participant reaches their primary endpoint (3 years post-treatment) and once all data have been collected and cleaned. There will be no formal interim analyses, but an independent data monitoring and ethics committee will review interim safety and accrual data to monitor trial progress. Procedures are in place to detect and address potential "researcher effects" and "researcher bias." |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Androgen Deprivation Therapy |
| Primary outcome measure | Current primary outcome measure as of 06/11/2024: 1. Metastatic free survival (defined as time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to Prostate Cancer (PCa)) measured using patient records 2. PROM-assessed late bowel toxicity at 3 years, measured using the Expanded Prostate Cancer Index Composite 26-item questionnaire (EPIC-26) bowel function sub-domain. Previous primary outcome measure: Metastatic free survival (defined as the time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to Prostate Cancer (PCa)) measured using patient records |
| Secondary outcome measures | Current secondary outcome measure as of 06/11/2024: 1. Overall survival (defined as the time from randomisation to death from any cause) 2. Biochemical progression-free survival (bPFS, defined as ≥2 ng/ml increase in PSA above the nadir value achieved after completion of RT) 3. Failure-free survival (defined as the time from randomisation to biochemical failure, the commencement of further anticancer therapy for PCa, further nodal, bone or visceral metastases or death from PCa) 4. Patterns of failure: Local, treated-node(s), other regional/ pelvic lymph node(s), para-aortic lymph node(s), other extra-pelvic lymph node(s), bone metastasis, visceral metastasis (liver, lung), other metastasis 5. Urinary and bowel toxicities, measured using the relevant EPIC-26 function and other sub-domains at baseline and 2 weeks, 3 months, 12 months, 24 months and 36 months post-RT 6. Health-Related Quality of Life (HRQoL), measured using EORTC QLQ-C30 at baseline and 2 weeks, 3 months, 12 months, 24 months and 36 months post-RT 7. Clinician-reported toxicity at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months post-RT and maximum acute (≤3 months) and late (>3 months) bowel and urinary toxicity, measured using CTCAE v5.0 Previous secondary outcome measure: PROM-assessed late bowel toxicity at 3 years, measured using the Expanded Prostate Cancer Index Composite 26-item questionnaire (EPIC-26) bowel function sub-domain. |
| Overall study start date | 01/10/2023 |
| Overall study end date | 30/11/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 480; UK Sample Size: 480 |
| Participant inclusion criteria | Current participant inclusion criteria as of 06/11/2024: 1. Age >=18 years, male 2. Histological diagnosis of prostate adenocarcinoma 3. Previous primary prostate cancer (PCa) treatment (radical prostatectomy [RP], primary/ post-operative radiotherapy [RT] or brachytherapy without previous pelvic nodal RT) 4. Maximum of three PET-CT (PSMA or Choline PET-CT) defined macroscopically-involved pelvic lymph nodes (upper limit of the pelvis is defined as the aortic bifurcation) within 6 months prior to randomisation 5. World Health Organisation (WHO) performance status 0-2 6. Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-20 7. Patients must be able to provide study-specific written informed consent 8. Prepared to participate in follow-up by telephone or in-person Previous participant inclusion criteria: 1. Age >=18 years, male 2. Histological diagnosis of prostate adenocarcinoma 3. Previous primary prostate cancer (PCa) treatment (radical prostatectomy [RP], primary/ post-operative radiotherapy [RT] or brachytherapy without previous pelvic nodal RT) 4. Maximum of three PET-CT defined macroscopically-involved pelvic lymph nodes (upper limit of the pelvis is defined as the aortic bifurcation) within 6 months prior to randomisation 5. World Health Organisation (WHO) performance status 0-2 6. Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-20 7. Patients must be able to provide study-specific written informed consent 8. Prepared to participate in follow-up by telephone or in-person |
| Participant exclusion criteria | 1. Previous pelvic nodal radiotherapy 2. Contraindications to SBRT or ENI (e.g. inflammatory bowel disease) 3. Contraindications to ADT 4. Local recurrence in the prostate gland 5. Para-aortic nodal metastases (above the aortic bifurcation) 6. Meso-rectal nodal metastases 7. Bone or visceral metastases 8. Severe late toxicity relating to primary/post-operative RT 9. Other active malignancy (except non-melanoma skin cancer or other malignancy with a documented disease-free survival for a minimum of 3 years before randomisation) 10. Castrate-resistant disease |
| Recruitment start date | 01/12/2024 |
| Recruitment end date | 30/11/2028 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
The Christie NHS Foundation Trust
550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Belfast Health and Social Care Trust
Trust Headquarters
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
NHS Lothian
Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Guys and St Thomas' NHS Foundation Trust
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE1 7EH
United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
United Lincolnshire Hospitals NHS Trust
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
East and North Hertfordshire NHS Trust
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Somerset NHS Foundation Trust
Trust Management
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
North Middlesex University Hospital NHS Trust
North Middlesex Hospital
Sterling Way
London
N18 1QX
United Kingdom
Sterling Way
London
N18 1QX
United Kingdom
Royal Free London NHS Foundation Trust
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
The Royal Marsden NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom
London
SW3 6JJ
United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
Torbay and South Devon NHS Foundation Trust
Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom
London
NW1 2PG
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Colchester Dist General Hospital
Turner Road
Colchester
CO4 5JL
United Kingdom
Turner Road
Colchester
CO4 5JL
United Kingdom
Greater Glasgow and Clyde
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Royal Cornwall Hospitals NHS Trust
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Mid and South Essex NHS Foundation Trust
Prittlewell Chase
Westcliff-on-sea
SS0 0RY
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Barts Health NHS Trust
The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Maidstone and Tunbridge Wells NHS Trust
The Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Imperial College Healthcare NHS Trust
The Bays
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Sponsor information
University of Leeds
University/education
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 113 343 7587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Yorkshire Cancer Research
No information available
Results and Publications
| Intention to publish date | 01/11/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | After the final trial results publication, researchers may request access to data from the POINTER-PC Trial Management Group and Leeds Cancer Research UK Clinical Trials Unit. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/12/2024 | 17/01/2025 | Yes | No |
Editorial Notes
17/01/2025: Publication reference added.
21/11/2024: IPD sharing plan updated.
07/11/2024: The recruitment end date was changed from 01/07/2028 to 30/11/2028.
06/11/2024: The following changes were made:
1. The overall study end date was changed from 30/11/2030 to 30/11/2031.
2. The primary and secondary outcome measures were changed.
3. The participant inclusion criteria were changed.
4. The recruitment start date was changed from 20/10/2024 to 01/12/2024.
11/06/2024: Study's existence confirmed by the NIHR.
