Aus 2002.
| Methods | Randomised study examining the use of hormone therapy neo‐adjuvant to prostatectomy in the treatment of prostate cancer (stage T1b‐3a, Nx, M0) Quality Score (1/0/1) | |
| Participants | Patients entered: 126
Patients evaluable: 111
Age (Mean): 67
Range: 50 ‐ 77 Eligibility Criteria: · Previously untreated prostate cancer · Histologically confirmed stage T1b‐3a, Nx, M0, G1‐3 · Aged = 75 years · Lifespan > 10 years · Diagnosis by histologically confirmed biopsies or TURP specimens Ineligibility Criteria: · Not Stated Exclusion Criteria: · 12 were excluded because of positive lymph nodes in frozen sections (9 in the control and 3 in the neo‐adjuvant group) · Another 3 patients not operated upon (1 moved abroad, 1 changed his mind in favour of radiotherapy, and 1 was disqualified from surgery owing to a newly detected aortic stenosis). |
|
| Interventions | Radical Prostatectomy alone Vs. 3 mths hormone treatment followed by Prostatectomy
Evaluable: 55 Vs. 56 Hormone Therapy: 3 months of Triptorelin (Decapeptyl Depot) administered as intra‐muscular injections (3.75mg) every fourth week N.B. To prevent tumour flare Cyproterone acetate (Androcur) was given 1 week before and 2 weeks after the first Triptorelin injection. |
|
| Outcomes | i. Histological grading ii. Positive surgical margin status iii. Crude overall survival iv. PSA progression free survival | |
| Notes | The main outcome of this study is surgical margins. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |