A randomised phase II trial of Prostate and pelvIs Versus prOsTate Alone treatment for Locally advanced prostate cancer

ISRCTN	ISRCTN48709247
DOI	https://doi.org/10.1186/ISRCTN48709247
ClinicalTrials.gov number	NCT01685190
Secondary identifying numbers	9468

Submission date: 11/02/2011
Registration date: 11/02/2011
Last edited: 03/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-2-different-ways-giving-radiotherapy-prostate-cancer

Study website

Contact information

Ms Rebecca Lewis
Scientific

Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Email	PIVOTAL-icrctsu@icr.ac.uk

Study information

Study design	Multicentre randomised interventional non-comparative treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised phase II trial of Prostate and pelvIs Versus prOsTate Alone treatment for Locally advanced prostate cancer
Study acronym	PIVOTAL
Study objectives	PIVOTAL is a non-comparative randomised study which aims to determine the feasibility and toxicity of treating locally advanced prostate cancer with escalated doses of radiotherapy to the prostate and pelvic nodes using intensity modulated radiotherapy (IMRT).
Ethics approval(s)	MREC, 25/08/2010, ref: 10/H1208/54
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
Intervention	1. Pelvis and prostate IMRT: 74 Gray to prostate and 60 Gray to pelvis in 37 fractions over 7.5 weeks 2. Prostate alone IMRT: 74 Gray in 37 fractions over 7.5 weeks Follow-up length: 24 months Study entry: single randomisation only
Intervention type	Other
Primary outcome measure	Acute gastrointestinal (GI) Radiation Therapy Oncology Group (RTOG) grade greater than or equal to 2 toxicity, measured 18 weeks from start of radiotherapy
Secondary outcome measures	1. Biochemical progression, measured throughout follow up 2. Compliance with dose volume constraints, measured throughout follow up 3. Disease-specific survival, measured throughout follow up 4. Local progression, measured throughout follow up 5. Lymph node (regional) progression, measured throughout follow up 6. Overall survival, measured throughout follow up 7. Patient reported outcomes, measured at baseline (pre-randomisation and pre-radiotherapy treatment), week 10, week 18 and at 6, 12, 18 and 2 years 8. Patterns of recurrence, measured throughout follow up 9. Time to distant progression, measured throughout follow up
Overall study start date	01/03/2011
Completion date	28/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	Planned sample size: 110; UK sample size: 110
Key inclusion criteria	1. Histologically confirmed, non-metastatic adenocarcinoma of the prostate, previously untreated (other than by neoadjuvant hormonal treatment) 2. National Collaborative Cancer Network locally advanced disease (T3b or T4) or estimated risk of pelvic lymph node involvement greater than or equal to 30% and either: 2.1. Gleason 9 or 10, or 2.2. Gleason 8 and one other high risk feature (T3 disease or prostate specific antigen [PSA] greater than 20), or 2.3. Gleason 7 and 2 high risk features (T3 disease and PSA greater than or equal to 30) 3. World Health Organization (WHO) performance status 0 or 1 4. Normal blood count (Hb greater than 11 g/dl, white blood cell count [WBC] greater than 4000/mm3, platelets greater than 100,00/mm3) 5. Hormonal therapy for 6 - 9 months duration prior to proposed radiotherapy treatment and PSA less than 4 ng/ml prior to randomisation 6. Testosterone level less than 20 ng/dL (0.7 nmol/L) 8. Patients must be prepared to attend follow up. All patients participating in the Patient Reported Outcomes (PRO) Study must have adequate cognitive ability to complete the PRO questionnaires. 9. Written informed consent 10. Male, aged 18 years or older
Key exclusion criteria	1. Prior pelvic radiotherapy 2. Prior major pelvic surgery (e.g. colectomy, colostomy, cystectomy, prostatectomy) 3. Radiologically suspicious (short axis diameter greater than or equal to 1.0 cm unless biopsied and negative) or pathologically confirmed lymph node involvement 4. Life expectancy less than 5 years 5. Castrate resistant prostate cancer (rising PSA after LHRHa and anti-androgen) 6. Previous active malignancy within the last 5 years other than basal cell carcinoma 7. Co-morbid conditions likely to impact on the decision to treat with radiotherapy (e.g. previous inflammatory bowel disease, previous colo-rectal surgery, significant bladder instability or urinary incontinence) 8. Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
Date of first enrolment	03/06/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trials & Statistics Unit (ICR-CTSU)

Sutton
SM2 5NG
United Kingdom

Sponsor information

Institute of Cancer Research (ICR) (UK)
Research organisation

Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Website	http://www.icr.ac.uk/
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request. Contact details are the same as in the contact information section. Clinical data are available for sharing subject to completion of a data sharing application form, approval by the trial oversight committees and completion of a data sharing agreement. As part of the review the trialists would consider whether the existing trial consent covers the application, what anonymisation will be required and whether separate ethics approval would be required.

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	15/07/2015	Yes	No
Results article	results	01/03/2019	Yes	No

Editorial Notes

03/01/2019: Plain English summary link and trial website updated, publication references and IPD sharing statement added.
19/12/2018: Cancer Research UK lay results summary link added to Results (plain English).
09/11/2017: No publications found in PubMed, verifying study status with principal investigator. ClinicalTrials.gov registration number has been added.