Following approval of the research protocol by the regional research council, cryoablation of the prostate gland with curative intent in early, organ confined malignancy (T I, T2, T3A, NO/NX) was introduced as an investigation procedure in January 1997. The procedure was offered as an equal treatment Opportunity to patients considered eligible for radical surgery.
Method: Preoperative investigations included bimanual rectal palpation, unrethrocystoscopy and transrectal ultrasound examination in general anesthesia. Skeletal isotope scanning was performed in all patients. Diagnostic pelvic lymphadenectomy was performed in patients with PSA above 15.
The cryoprocedure was performed in general anesthesia with the Accurprobe system using liquid supercooled nitrogen. Five freezing probes were inserted transperineally using transrectal biplane ultrasound system (B&K) surveillance and guided into proper positions in order to freeze the gland and surrounding tissues. Freezing was immediately repeated after thawing, with reposition of probes if deemed necessary. The integrity of the circulation in the rectal wall was monitored with Doppler technique. A suprapubic catheter was introduced at the start of the procedure and removed when spontaneous voiding was attained. A complete reevaluation was performed after 3-4 months. 76 patients have been treated (mean age 63, range 50-70). Nine men had tumor with histologic grade 1, 61 had grade 2 and 6 had grade 3 (WHO). One patient had stage T I tumor, 64 had stage T I I and I I had stage T3A (WHO). 28 patients had diagnostic lymphadenectomy with negative histology (NO). In 47 men with PSA 15 lymphadenectomy was not performed. Mean pretreatment PSA was 13.4
Results: The mean follow up of all 76 patients is 9,7 months (range 1-20). The mean hospital stay is 2-3 days. 60 of 76 patients have been evaluated after 3-4 months, with a mean follow up 11.2 months (range 4-20), with these results: Histologic grade in these 60 patients was grade 1:7, grade 2:48 and grade 3:5. Clinical stages were T 1: 1, T2:51 and T3A: 8. PSA mean was prior to treatment: 11.2 and after 3-4 months 0.45 (range 0.0-28). In 21 patients, PSA was not measurable after 3 to 4 months. Pretreatment prostatic volume was 32cc. The men volume after 3-4 months was 19 cc (range 4-47). Systematic biopsies of the gland disclosed no malignancy in 56 of 60 patients (93.3%). Residual malignancy was found in 4 of 60 patients (6.7%).
Wound Infection 0
Stricture of the urethra 0
Needed TLJR-P 5
Pyuri after 3-4mths 16 (26.6%)
Epididymitis 4 (6.6%)
Rectal fistula 0
Conclusion: The therapeutic impact of radical surgery, radiotherapy and "wait and see" has never been properly evaluated in controlled clinical trials. Thus, these traditional treatment options, while established, are still properly regarded as experimental. Moreover, their complication profile is not entirely benign. Cryoablation is a novel experimental treatment procedure. Compared to established alternatives, the complication profile seems to be highly acceptable. The 93.3 negative histology rate and the high rate of zero or very low PSA level at evaluation at 3 -4 months seems highly promising.
Further evaluation of the procedure seems appropriate.