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A Study of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer (PIVOTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01685190
Recruitment Status : Active, not recruiting
First Posted : September 14, 2012
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE September 14, 2012
Last Update Posted Date January 4, 2019
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
Acute lower GI RTOG toxicity at week 18 of follow-up. [ Time Frame: 18 weeks post treatment ]
Proportion of patients with acute GI RTOG grade ≥2 toxicity at week 18 from start of radiotherapy calculated as the number of patients with grade ≥2 toxicity at week 18 over the number of evaluable at week 18.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
  • Ability to deliver 60Gy in 37 fractions to the pelvis using the varying radiotherapy planning techniques and delivery systems at the participating centres. [ Time Frame: 2 yr ]
  • Late (1 and 2 year) toxicity [ Time Frame: 2 yr ]
    Measured using RTOG toxicity scale and CTCAE
  • Patient Reported Outcomes [ Time Frame: 2 yr ]
    Participants are requested to complete questionnaires to record the impact of the treatments on bowel and bladder function.
  • Biochemical progression free survival [ Time Frame: 10 yr ]
  • Time to local progression [ Time Frame: 10 yr ]
  • Time to distant metastases [ Time Frame: 10 yr ]
  • Overall survival [ Time Frame: 10 yr ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer
Official Title  ICMJE A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer
Brief Summary

Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed annually. 35% of these are locally advanced disease. These patients have a high chance of pelvic lymph node involvement and have relatively poor prostate cancer survival rates of 22.5% at 10 years.

One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL is a multi-centre phase II non-comparative randomised feasibility trial, in which patients with a high chance of pelvic lymph node involvement are randomised between prostate radiotherapy alone and prostate + pelvic radiotherapy.

Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT). This is a relatively new method of shaping radiotherapy treatment beams which allows the tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this has been tested in a single hospital, single group setting and levels of side effects (toxicity) were acceptable.

PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy remain acceptable when treatment is given in multiple cancer centres across the UK. It is randomised to ensure unbiased collection of acute toxicity data and to provide information on patients' willingness to participate in a randomised study. Should the phase II study be successful, the investigators would develop a phase III trial to compare treatment effectiveness (disease control).

Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy and data relating to toxicity will be collected. They will also be asked to complete patient related symptoms questionnaires. Data related to disease recurrence will then be collected annually from patients' standard hospital visits.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Prostate alone IMRT
    Participants will receive standard prostate IMRT of 74Gy in 37 fractions delivered over 7.5 weeks.
  • Radiation: Prostate and pelvis IMRT
    Participants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.
Study Arms  ICMJE
  • Active Comparator: Prostate Alone IMRT
    Participants will receive standard prostate Intensity Modulated Radiotherapy (IMRT) of 74Gy in 37 fractions delivered over 7.5 weeks.
    Intervention: Radiation: Prostate alone IMRT
  • Experimental: Prostate & Pelvis IMRT
    Participants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.
    Intervention: Radiation: Prostate and pelvis IMRT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
124
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2012)
110
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)43 or:

    • Estimated risk of pelvic lymph node involvement ≥30% * and either:

    • Gleason 9 or 10 or
    • Gleason 8 and one other high risk feature (T3± disease or PSA >20) or
    • Gleason 7 and 2 high risk features (T3± disease and PSA ≥30)
  3. WHO performance status 0 or 1
  4. Normal blood count (Hb > 11g/dl, WBC >4000/mm3, platelets >100,000/mm3)
  5. LHRH analogue therapy for 6-9 months duration prior to proposed radiotherapy treatment and PSA < 4ng/ml prior to randomisation.
  6. Age ≥ 18 years
  7. 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.
  8. Written informed consent

    • T3a disease should be demonstrated convincingly, either clinically or by MRI. T3b disease (seminal vesicle involvement) must be convincingly demonstrated on MR.

      • Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA

Exclusion criteria:

  1. Prior pelvic radiotherapy
  2. Prior major pelvic surgery (e.g. colectomy, colostomy, cystectomy, prostatectomy)*
  3. Radiologically suspicious (short axis diameter ≥1.0cm unless biopsied and negative) or pathologically confirmed lymph node involvement
  4. Life expectancy < 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

    • Patients who have undergone minor pelvic surgery will be eligible (eg appendicectomy, trans urethral resection of prostate (TURP), exploratory laparoscopy, haemorrhoidectomy, inguinal/femoral hernia repair)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685190
Other Study ID Numbers  ICMJE ICR-CTSU/2010/10025
CRUK/10/022 ( Other Grant/Funding Number: CRUK )
ISRCTN48709247 ( Registry Identifier: ISRCTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Cancer Research, United Kingdom
Study Sponsor  ICMJE Institute of Cancer Research, United Kingdom
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE
Principal Investigator: Prof. David Dearnaley Institute of Cancer Research/RMHNHSFT
PRS Account Institute of Cancer Research, United Kingdom
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP