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A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Randomised Phase II Trial of Prostate and pelvIs Versus prOsTate Alone Treatment for Locally Advanced Prostate Cancer

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute lower GI RTOG toxicity at week 18 of follow-up.

Outcome Description:

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.

Outcome Time Frame:

18 weeks post treatment

Safety Issue:


Principal Investigator

Prof. David Dearnaley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Cancer Research/RMHNHSFT


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

June 2011

Completion Date:

March 2018

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms