A phase III randomised controlled trial of prostate and pelvis versus prostate alone radiotherapy with or without prostate boost
- Conditions
- Prostate cancerCancer
- Registration Number
- ISRCTN80146950
- Lead Sponsor
- Institute Of Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Male
- Target Recruitment
- 1952
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 <50ng/ml prior to starting ADT.
3. NCCN localised high risk or locally advanced disease: T3a, T3b or T4 N0M0 (clinical and/or MRI) and/or Dominant Gleason 4 or 5 (grade group 3, 4, or 5) and/or 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) >6mm 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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method