Prostate cancer Cancer Cancer
Conditions
Interventions
Participants are allocated to one of the following treatment arms:
A: Prostate alone Intensity-modulated radiation therapy (IMRT)
B: Prostate and pelvic IMRT
C: Prostate IMRT and prostate boost
D: Pr
Sponsors
Institute Of Cancer Research
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, previously untreated, non-metastatic adenocarcinoma of the prostate using the Gleason scoring or grade group system (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old). 2. PSA 20; or 3.1. NCCN intermediate risk disease: T2b-c N0M0, and/or Gleason 3+4 (grade group 2) and /or PSA 10-20 ng/ml and Adverse feature, for example: Maximum tumour length (MTL) >6 mm and/or ?50% biopsy cores positive and / or PI-RADS score 3, 4 or 5, DIL lesion >10mm axial dimension on staging MRI. 4. Age =18 years 5. Signed, written informed consent 6. WHO performance status 0-2 (Appendix 1)
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the prostate or pelvis 2. Prior radical prostatectomy 3. Prior ADT for > 6 months at consent (as patients will need to commence radiotherapy at months 3-5 (maximum 7) following start of ADT) 4. Adjuvant docetaxel chemotherapy 5. Radiologically suspicious or pathologically confirmed lymph node involvement 6. Evidence of metastatic disease 7. Life expectancy < 5 years 8. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts and would make pelvic node planning more difficult 9. For patients having fiducials inserted: Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. 10. For patients being considered for randomisation options C2 and D2 only and are undergoing a planning MRI scan: Contraindication to undergo a MRI scan. 11. For undergoing HDR brachytherapy: long-term anticoagulation therapy which cannot be temporarily stopped, prostate surgery (TURP) with a significant tissue cavity, a history of recent deep vein thrombosis or pulmonary embolus, significant cardiovascular comorbidity, unfit for prolonged general anaesthetic. 12. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms 13. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival 14. Any other contraindication to external beam radiotherapy to the pelvis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival is measured by the time to first biochemical failure, recommencement of androgen deprivation therapy, local recurrence, lymph node/pelvic recurrence, distant metastases or death due to prostate cancer for up to 10 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to loco-regional recurrence; time to biochemical failure or prostate recurrence; metastatic relapse free survival; overall and prostate cancer specific survival; time to recommencement of androgen deprivation therapy is measured using clinical assessment of disease status up to 10 years 2. Adherence to dose constraints is measured using collection of radiotherapy treatment doses/parameters at treatment 3. Acute bladder and bowel toxicity is measured using RTOG and CTC (v4.0) adverse event reporting at 3 months 4. Late toxicity is measured using RTOG and CTC (v4.0) adverse event reporting up to 10 years 5. Quality of life is measured using ALERT-B (Assessment of Late Effects of RadioTherapy - Bowel) screening tool, Gastrointestinal Symptom Rating Scale (GSRS), IIEF-5 Questionnaire (SHIM), International Prostate Symptom Score (IPSS), and Expanded Prostate Index Composite-26 (EPIC-26) Short Form questionnaire up to 10 years 6. Health economic endpoints are measured using EQ-5D up to 10 years | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactShama Hassan
Outcome results
None listed