Condition category
Cancer
Date applied
11/02/2011
Date assigned
11/02/2011
Last edited
18/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Rebecca Lewis

ORCID ID

Contact details

Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
-
PIVOTAL-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9468

Study information

Scientific title

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

Acronym

PIVOTAL

Study hypothesis

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

MREC on 25/08/2010 (ref: 10/H1208/54)

Study design

Multicentre randomised interventional non-comparative treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned sample size: 110; UK sample size: 110

Participant 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

Recruitment start date

03/06/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials & Statistics Unit (ICR-CTSU)
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (ICR) (UK)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes