© 2006 THE AUTHORS JOURNAL COMPILATION © 2 0 0 6 B J U I N T E R N A T I O N A L | doi:10.1111/j.1464-410X.2006.06520.x 1 Original Article BIOCHEMICAL RELAPSE-FREE SURVIVAL AFTER BRACHYTHERAPY KHAKSAR et al. Biochemical (prostate-specific antigen) relapse-free survival and toxicity after 125 I low-dose-rate prostate brachytherapy Sara Jane Khaksar, Robert W. Laing, Alastair Henderson* Prasanna Sooriakumaran*, David Lovell† and Stephen E.M. Langley* Departments of Clinical Oncology, St. Luke’s Cancer Centre, *Urology, Royal Surrey County Hospital, Guildford, and †Statistics, Postgraduate Medical School, University of Surrey, Surrey, UK Accepted for publication 24 July 2006 RESULTS The median (range) follow-up was 45 (33–82) months. The actuarial PSA relapse- free survival was 93% at 5 years; 21 (7%) of patients had evidence of biochemical failure as defined by the American Society of Therapeutic Radiation Oncology criteria. There was no significant difference in actuarial survival for patients in the different risk groups, or between those receiving NAAD or not (low-risk 96%, intermediate 89%, high 93%, P = 0.12; NAAD 92%, no NAAD 95%, P = 0.30). Overall the 3-year median PSA level was 0.3 ng/mL (192 men). There was no significant difference in median 3-year PSA levels for different risk groups, or for those treated with or with no NAAD. The 3- and 4- year PSA nadir of < 0.5 ng/mL was achieved by 71% and 86% of men, respectively. The acute urinary retention rate was 7%; 5.6% of men developed urethral strictures requiring dilatation, while 2.7% required a transurethral resection of the prostate after implantation, for obstructive symptoms. Of patients with no ED before treatment, 62% had no ED at 2 years, and of these 60% used a phosphodiesterase inhibitor. CONCLUSION This prospective series confirms the excellent overall biochemical survival after 125 I brachytherapy; the treatment was tolerated well, with early and late urinary toxicity and ED similar to other published results. KEYWORDS prostate carcinoma, brachytherapy, survival, urinary toxicity, erectile dysfunction OBJECTIVE To report our clinical experience and 5-year prostate-specific antigen (PSA) relapse-free survival rate for early-stage prostate cancer after 125 I low-dose-rate prostate brachytherapy. PATIENTS AND METHODS In all, 300 patients were treated between March 1999 and April 2003, and followed prospectively. Patients were stratified into low-, intermediate- and high-risk groups, and those receiving neoadjuvant androgen deprivation (NAAD) or not. Kaplan–Meier estimates of PSA relapse-free survival and PSA nadirs were obtained for all patients and for the risk groups. Toxicity, as urinary and erectile dysfunction (ED), were reported from a prospective database. INTRODUCTION Recent guidelines from the UK National Institute of Clinical Excellence supporting the use of low-dose-rate (LDR) brachytherapy for localized prostate cancer call for continued audit and careful clinical governance. We here report our clinical experience and 5-year PSA relapse-free survival for this treatment. The accepted radical treatment options for early prostate cancer include radical prostatectomy, conformal external beam radiotherapy (EBRT) and transperineal interstitial LDR brachytherapy. The 5- and 10-year biochemical (PSA) relapse-free survival rates after brachytherapy, reported from the USA, have been shown to be equivalent to those from the best series of radical prostatectomy and conformal EBRT [1–5]. Prostate brachytherapy has been used at the authors’ cancer centre since March 1999; to date > 750 men presenting with early prostate cancer have been treated, and followed prospectively. We report our clinical experience and results from the first 300 consecutive patients treated, who have a follow-up of ≥ 33 months. PATIENTS AND METHODS All patients were assessed before treatment with a medical history, physical examination, TRUS, the IPSS and uroflowmetry. Baseline erectile function was evaluated using the International Index of Erectile Function-5 (IIEF-5). Clinical stage, PSA levels and Gleason score were documented, with pelvic MRI and bone scans used if clinically indicated. Patients were classified as having low-, intermediate- or high-risk disease [6]; those with low-risk disease (stage ≤ T2b, PSA level ≤ 10 ng/mL and Gleason sum ≤ 6) received brachytherapy alone, with intermediate-risk disease (one unfavourable factor of stage ≥ T2c, PSA level > 10 ng/mL or Gleason ≥ 7) 3 months of neoadjuvant androgen deprivation (NAAD) and brachytherapy, and those with high-risk disease (two unfavourable factors) a combination of NAAD, EBRT and brachytherapy. Patients whose treatment did not adhere to these guidelines were so treated as a result of individual factors such as multiple positive biopsies, perineural invasion on biopsy, young age ( < 60 years) or delay in treatment decision and waiting times. The prescribed dose for 125 I-monotherapy was 145 Gy and combined