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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01685190
First received: October 26, 2011
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Prostate alone IMRT
Radiation: Prostate and pelvis IMRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • Acute lower GI RTOG toxicity at week 18 of follow-up. [ Time Frame: 18 weeks post treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Late (1 and 2 year) toxicity [ Time Frame: 2 yr ] [ Designated as safety issue: Yes ]
    Measured using RTOG toxicity scale and CTCAE

  • Patient Reported Outcomes [ Time Frame: 2 yr ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to local progression [ Time Frame: 10 yr ] [ Designated as safety issue: No ]
  • Time to distant metastases [ Time Frame: 10 yr ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 10 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: June 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prostate Alone IMRT
Participants will receive standard prostate Intensity Modulated Radiotherapy (IMRT) of 74Gy in 37 fractions delivered over 7.5 weeks.
Radiation: Prostate alone IMRT
Participants will receive standard prostate IMRT of 74Gy in 37 fractions delivered over 7.5 weeks.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685190

Locations
United Kingdom
Queen Elizabeth
Birmingham, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Hospital
Cardiff, United Kingdom
Ipswich
Ipswich, United Kingdom
Clatterbridge Centre for Oncology
Liverpool, United Kingdom
Royal Marsden NHSFT
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Investigators
Principal Investigator: Prof. David Dearnaley Institute of Cancer Research/RMHNHSFT
  More Information

No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01685190     History of Changes
Other Study ID Numbers: ICR-CTSU/2010/10025, CRUK/10/022, ISRCTN48709247
Study First Received: October 26, 2011
Last Updated: April 3, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014