Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. Refer to the PDQ levels of evidence summary for more information.

T1a, N0, M0, well-differentiated (stage A1)

The frequency of clinically silent, nonmetastatic prostate cancer that can be found at autopsy greatly increases with age, and may be as high as 50% to 60% in men aged 90 and over. Undoubtedly, the incidental discovery of these occult cancers at prostatic surgery performed for other reasons accounts for the similar survival of men with stage I prostate cancer compared to the normal male population, adjusted for age. Many stage I cancers are well-differentiated and only focally involve the gland (T1a, N0, M0), and the majority require no treatment other than careful follow-up.[1] In a retrospective pooled analysis, 828 men with clinically localized prostate cancer were managed by initial conservative therapy with subsequent hormone therapy given at the time of symptomatic disease progression. This study showed that the patients with grade 1 or 2 tumors experienced a disease-specific survival of 87% at 10 years and that their overall survival closely approximated the expected survival among men of similar ages in the general population.[2] However, in younger patients (age 50-60) whose expected survival is long, treatment should be considered.[3] Less differentiated cancers that involve more than a few pieces of resected tissue (T1b, N0, M0) are biologically more aggressive. However, the trial of 95 patients was not large enough to exclude a small but medically significant difference in overall survival, nor did it include information to measure time to progression, cancer-specific survival, or quality of life. Radical prostatectomy, external-beam radiation therapy, and interstitial implantation of radioisotopes and watchful waiting yield apparently similar survival rates in noncontrolled selected series. The decision to treat should be made in the context of the patient's age, associated medical illnesses, and the patient's personal desires.[3]

Treatment options:

1. Careful observation without further immediate treatment in selected patients.[2-5]

2. External-beam radiation therapy.[6-10] Definitive radiation therapy should be delayed 4 to 6 weeks after transurethral resection to reduce incidence of stricture.[11]

3. Radical prostatectomy usually with pelvic lymphadenectomy (with or without the nerve sparing technique designed to preserve potency).[12-14] Radical prostatectomy may be difficult after a transurethral resection of the prostate. Consideration may be given to postoperative radiation therapy for patients who are found to have capsular penetration or seminal vesicle invasion by tumor at the time of prostatectomy or have a detectable level of prostate-specific antigen more than 3 weeks after surgery.[15-20] Because duration of follow-up in available studies is still relatively short, the value of postoperative radiation therapy is yet to be determined. However, postoperative radiation therapy does reduce local recurrence.[21] Careful treatment planning is necessary to avoid morbidity.[15-20] Clinical trials are in progress.

4. Interstitial implantation of radioisotopes (i.e., I-125, palladium, iridium) done through a transperineal technique with either ultrasound or CT guidance is being done in carefully selected patients with T1 or T2A tumors. Short term results in these patients are similar to those for radical prostatectomy or external-beam radiation therapy.[22-24][Level of evidence: 3iiiDiii] One advantage is that the implant is performed as outpatient surgery. The rate of maintenance of sexual potency with interstitial implants has been reported to be 86% to 92%, [22,24] which compares with rates of 10% to 40% with radical prostatectomy and 40% to 60% with external-beam radiation therapy. However, urinary tract frequency, urgency, and less commonly, urinary retention are seen in most patients but subside with time. Rectal ulceration may also be seen. In 1 series, a 10% 2-year actuarial genitourinary grade 2 complication rate and a 12% risk of rectal ulceration was seen. This risk decreased with increased operator experience and modification of implant technique.[22] Long-term follow-up of these patients is necessary to assess treatment efficacy and side effects.

Retropubic freehand implantation with I-125 has been associated with an increased local failure and complication rate [25,26] and is now rarely done.

5. External-beam radiation therapy designed to decrease exposure of normal tissues using methods such as computed tomography-based 3-D conformal treatment planning is under clinical evaluation.[27]

6. Other clinical trials. Refer to PDQ or to CancerNet (http://cancernet.nci.nih.gov) for information on clinical trials for patients with early stage prostate cancer

1. National Institutes of Health: National Institute of Health Consensus Development Conference statement: the management of clinically localized prostate cancer. Journal of the American Medical Association 258(19): 2727-2730, 1987.
2. Chodak GW, Thisted RA, Gerber GS, et al.: Results of conservative management of clinically localized prostate cancer. New England Journal of Medicine 330(4): 242-248, 1994.
3. Epstein JI, Paull G, Eggleston JC, et al.: Prognosis of untreated stage A1 prostatic carcinoma: a study of 94 cases with extended follow-up. Journal of Urology 136(4): 837-839, 1986.
4. Graversen PH, Nielsen KT, Gasser TC, et al.: Radical prostatectomy versus expectant primary treatment in stages I and II prostatic cancer: a fifteen-year follow-up. Urology 36(6): 493-498, 1990.
5. Cantrell BB, DeKlerk DP, Eggleston JC, et al.: Pathological factors that influence prognosis in stage A prostatic cancer: the influence of extent versus grade. Journal of Urology 125(4): 516-520, 1981.
6. Bagshaw MA: External radiation therapy of carcinoma of prostate. Cancer 45(7): 1912-1921, 1980.
7. Forman JD, Zinreich E, Lee DJ, et al.: Improving the therapeutic ratio of external beam irradiation for carcinoma of the prostate. International Journal of Radiation Oncology, Biology, Physics 11(12): 2073-2080, 1985.
8. Ploysongsang S, Aron BS, Shehata WM, et al.: Comparison of whole pelvis versus small-field radiation therapy for carcinoma of prostate. Urology 27(1): 10-16, 1986.
9. Pilepich MV, Bagshaw MA, Asbell SO, et al.: Definitive radiotherapy in resectable (stage A2 and B) carcinoma of the prostate: results of a nationwide overview. International Journal of Radiation Oncology, Biology, Physics 13(5): 659-663, 1987.
10. Amdur RJ, Parsons JT, Fitzgerald LT, et al.: The effect of overall treatment time on local control in patients with adenocarcinoma of the prostate treated with radiation therapy. International Journal of Radiation Oncology, Biology, Physics 19(6): 1377-1382, 1990.
11. Seymore CH, El-Mahdi AM, Schellhammer PF: The effect of prior transurethral resection of the prostate on post radiation urethral strictures and bladder neck contractures. International Journal of Radiation Oncology, Biology, Physics 12(9): 1597-1600, 1986.
12. Zincke H, Bergstralh EJ, Blute ML, et al.: Radical prostatectomy for clinically localized prostate cancer: long-term results of 1,143 patients from a single institution. Journal of Clinical Oncology 12(11): 2254-2263, 1994.
13. Catalona WJ, Bigg SW: Nerve-sparing radical prostatectomy: evaluation of results after 250 patients. Journal of Urology 143(3): 538-544, 1990.
14. Catalona WJ, Basler JW: Return of erections and urinary continence following nerve sparing radical retropubic prostatectomy. Journal of Urology 150(3): 905-907, 1993.
15. Lange PH, Reddy PK, Medini E, et al.: Radiation therapy as adjuvant treatment after radical prostatectomy. Journal of the National Cancer Institute Monographs 7: 141-149, 1988.
16. Ray GR, Bagshaw MA, Freiha F: External beam radiation salvage for residual or recurrent local tumor following radical prostatectomy. Journal of Urology 132(5): 926-930, 1984.
17. Carter GE, Lieskovsky G, Skinner DG, et al.: Results of local and/or systemic adjuvant therapy in the management of pathological stage C or D1 prostate cancer following radical prostatectomy. Journal of Urology 142(5): 1266-1271, 1989.
18. Freeman JA, Lieskovsky G, Cook DW, et al.: Radical retropubic prostatectomy and postoperative adjuvant radiation for pathological stage C (PCN0) prostate cancer from 1976 to 1989: intermediate findings. Journal of Urology 149(5): 1029-1034, 1993.
19. Stamey TA, Yang N, Hay AR, et al.: Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. New England Journal of Medicine 317(15): 909-916, 1987.
20. Hudson MA, Bahnson RR, Catalona WJ: Clinical use of prostate specific antigen in patients with prostate cancer. Journal of Urology 142(4): 1011-1017, 1989.
21. Paulson DF, Moul JW, Walther PJ: Radical prostatectomy for clinical stage T1-2N0M0 prostatic adenocarcinoma: long-term results. Journal of Urology 144: 1180-1184, 1990.
22. Wallner K, Roy J, Harrison L: Tumor control and morbidity following transperineal iodine 125 implantation for stage T1/T2 prostatic carcinoma. Journal of Clinical Oncology 14(2): 449-453, 1996.
23. D'Amico AV, Coleman CN: Role of interstitial radiotherapy in the management of clinically organ-confined prostate cancer: the jury is still out. Journal of Clinical Oncology 14(1): 304-315, 1996.
24. Ragde H, Blasko JC, Grimm PD, et al.: Interstitial iodine-125 radiation without adjuvant therapy in the treatment of clinically localized prostate carcinoma. Cancer 80(3): 442-453, 1997.
25. Kuban DA, El-Mahdi AM, Schellhammer PF: I-125 interstitial implantation for prostate cancer. What have we learned 10 years later? Cancer 63(12): 2415-2420, 1989.
26. Fuks Z, Leibel SA, Wallner KE, et al.: The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. International Journal of Radiation Oncology, Biology, Physics 21(3): 537-547, 1991.
27. Hanks GE, Hanlon AL, Schultheiss TE, et al.: Dose escalation with 3D conformal treatment: five year outcomes, treatment optimization, and future directions. International Journal of Radiation Oncology, Biology, Physics 41(3): 501-510, 1998.

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