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

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate; Cancer; Prostate cancer

• Registration Number: ISRCTN48709247
• Lead Sponsor: Institute of Cancer Research (ICR) (UK)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26104940 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30528653

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-11
• Study Completion: 2013-02-28
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 110

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Biochemical progression, measured throughout follow up<br> 2. Compliance with dose volume constraints, measured throughout follow up<br> 3. Disease-specific survival, measured throughout follow up<br> 4. Local progression, measured throughout follow up<br> 5. Lymph node (regional) progression, measured throughout follow up<br> 6. Overall survival, measured throughout follow up<br> 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<br> 8. Patterns of recurrence, measured throughout follow up<br> 9. Time to distant progression, measured throughout follow up<br>