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The Incidence of Transition Zone Prostate Cancer Diagnosed by Transperineal Template Guided Mapping Biopsy: Implications for Treatment Planning
Proceedings of the 52nd Annual ASTRO Meeting Purpose/Objective(s): External beam radiation therapy and low dose rate permanent brachytherapy are commonly used to treat men with localized prostate cancer. This phase II trial was performed to document late GI and GU toxicity as well as biochemical control for this treatment in a multi-institutional cooperative group setting. This report defines the long-term results of this trial. Materials/Methods: All eligible patients received external beam radiation (45 Gy in 25 fractions) followed (2-6 weeks later) by a permanent iodine 125 implant of 108 Gy. Late toxicity was defined by the RTOG /EORTC late radiation morbidity scoring scheme. Biochemical control was defined by the ASTRO Consensus definition and the ASTRO Phoenix definition. Results: One hundred thirty-eight patients were enrolled from 20 institutions and 131 were eligible. Median follow-up (living patients) was 7.9 years (range, 2.7-8.7 years). The 8-year estimate of late $ grade 3 GU or/GI toxicity was 15%. The most common $ Grade 3 toxicities were cystitis/hematuria and proctitis. There were two Grade 4 toxicities both bladder necrosis, and no Grade 5 toxicities. In addition, 42% of patients complained of Grade 3 impotence (no erections) at eight years. The 8-year estimate of biochemical failure was 18% and 21% by the Phoenix and ASTRO consensus definitions, respectively. Conclusions: Biochemical control for this treatment seems durable with 8 years of follow-up and is similar to high-dose external beam radiation alone or brachytherapy alone. Late toxicity in this multi-institutional trial is higher than reports from similar cohorts of patients treated with high dose external beam radiation alone perhaps suggesting further attention to strategies that limit doses to normal structures or to unimodal radiotherapy techniques. ‘‘This project was supported by RTOG grant U10 CA21661, and CCOP grant U10 CA37422 from the National Cancer Institute (NCI).’’ Author Disclosure: C.A. Lawton, None; Y. Yan, None; W.R. Lee, None; M. Gillin, None; S. Firat, None; M. Baikadi, None; J. Crook, None; M. Kuettel, None; G. Morton, None; H. Sandler, None.
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The Incidence of Transition Zone Prostate Cancer Diagnosed by Transperineal Template Guided Mapping Biopsy: Implications for Treatment Planning
V. Patel1, G. S. Merrick2, Z. A. Allen2, W. M. Butler2, E. Adamovich3, K. E. Wallner4 Schiffler Cancer Center, Wheeling, WV, 2Schiffler Cancer Center/Wheeling Jesuit University, Wheeling, WV, 3Wheeling Hospital, Dept of Pathology, Wheeling, WV, 4Puget Sound Healthcare Corporation, Seattle, WA 1
Purpose/Objective(s): Because of the need to spare the urethra and periurethral regions, the efficacy of some minimally invasive treatments such as cryotherapy and HIFU are dependent on the absence of transition zone prostate cancer. In contrast, standard urethral doses in modern brachytherapy series range from 100-140% of prescription dose. These doses are more than sufficient to sterilize periurethral/transition zone cancer. In this study, we report the incidence of transition zone cancer in patients undergoing transperineal template guided mapping biopsy (TTMB). Materials/Methods: Five hundred thirty-nine consecutive patients underwent TTMB by means of an anatomic technique with sampling of 24 arbitrarily defined prostate regions. The position of each biopsy core was recorded in three dimensions. For every patient, the location of each positive biopsy core, the number of positive cores, the Gleason score, the percent involvement of each core and the present/absence of perineural invasion was documented. Results: The median volumetric prostate volume was 56.0cm3 with an ellipsoid transition zone volume of 20.1cm3. The median number of total TTMB cores was 58 with a median of 11 transition zone cores. Two hundred eighty-seven (63.2%) were diagnosed with prostate cancer. Transition zone cancer was detected in 130 (45.3%) of the patients with prostate cancer. Overall 38.9% of the transition zone cores were positive for malignancy. of the 130 transition zone cancers, 37 (28.5%), 64 (49.2%) and 29 (22.3%) were assigned Gleason score 6, 7, and 8-10 histology. Compared to a standard 12 core biopsy approach, the results of the transition zone biopsy upgraded the Gleason score in 24.6% of patients. of the 130 patients with transition zone cancer, only 4 (3.1%) were classified as clinically insignificant. Conclusions: Transperineal template guided mapping biopsy detects transition zone cancer in 45.3% of patients. Unlike brachytherapy, cryosurgery and HIFU must spare the periurethral region to preserve adequate urethral function and are unlikely to eradicate transition zone cancer in patients with such involvement. TTMB should be considered prior to any minimally invasive treatment, which spares the periurethral/transition zone region. Author Disclosure: V. Patel, None; G.S. Merrick, None; Z.A. Allen, None; W.M. Butler, None; E. Adamovich, None; K.E. Wallner, None.
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RTOG 0537 Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) versus Pilocarpine in Treating Early Radiation-Induced Xerostomia (RIX): Phase II Results
R. K. Wong1, J. L. James2, S. Sagar1, G. Wyatt3, P. F. Nguyen-Tan4, A. K. Singh5, B. Lukaszczyk6, F. Cardinale7, A. M. Yeh8, L. Berk9 1
McMaster University, Juravinski Cancer Center, Hamilton, ON, Canada, 2RTOG Statistical Center, Philadelphia, PA, Michigan State University, East Lansing, MI, 4Centre Hospitalier de L’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 5Roswell Park Cancer Institute, Buffalo, NY, 6John H. Stroger, Jr. Hospital of Cook County MBCCOP, Chicago, IL, 7 Hospital of St. Raphael, New Haven, CT, 8Clarion Health Partners Inc., Indianapolis, IN, 9University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL 3
Purpose/Objective(s): Current treatment for RIX mainly relies on cholinergic agents with moderate side effects. A single institutional phase I/II study suggested ALTENS improves RIX with better xerostomia symptom scores and increased whole saliva production (WSP) with no significant side effects. We are examining ALTENS versus pilocarpine in treating RIX in a multicenter phase II/III randomized prospective study. Primary: Determine ALTENS treatment feasibility (delivered via the Codetron unit) in a cooperative group setting. Secondary: Evaluate ALTENS effect on xerostomia burden, as measured by the University of Michigan Xerostomia Related Quality of Life Scale at 6 months from registration (6 mth XeQOLS). Materials/Methods: Eligible patients (pts) had no evidence of recurrent disease and had completed, either standard or IMRT radiotherapy + chemotherapy (RT+C) $ 3 months to 2 years. All had grade 1-2 xerostomia (CTCAE v3.0) and had basal WSP $ 0.1 mL/min. Use of pilocarpine/cevimeline was discontinued .2 weeks prior to treatment. Pts were to receive twice weekly ALTENS sessions for a total of 24 (20 minutes) sessions over 12 weeks. Pts who completed $ 19 sessions were considered compliant.
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The Incidence of Transition Zone Prostate Cancer Diagnosed by Transperineal Template Guided Mapping Biopsy: Implications for Treatment Planning
V. Patel1, G. S. Merrick2, Z. A. Allen2, W. M. Butler2, E. Adamovich3, K. E. Wallner4 Schiffler Cancer Center, Wheeling, WV, 2Schiffler Cancer Center/Wheeling Jesuit University, Wheeling, WV, 3Wheeling Hospital, Dept of Pathology, Wheeling, WV, 4Puget Sound Healthcare Corporation, Seattle, WA 1
Purpose/Objective(s): Because of the need to spare the urethra and periurethral regions, the efficacy of some minimally invasive treatments such as cryotherapy and HIFU are dependent on the absence of transition zone prostate cancer. In contrast, standard urethral doses in modern brachytherapy series range from 100-140% of prescription dose. These doses are more than sufficient to sterilize periurethral/transition zone cancer. In this study, we report the incidence of transition zone cancer in patients undergoing transperineal template guided mapping biopsy (TTMB). Materials/Methods: Five hundred thirty-nine consecutive patients underwent TTMB by means of an anatomic technique with sampling of 24 arbitrarily defined prostate regions. The position of each biopsy core was recorded in three dimensions. For every patient, the location of each positive biopsy core, the number of positive cores, the Gleason score, the percent involvement of each core and the present/absence of perineural invasion was documented. Results: The median volumetric prostate volume was 56.0cm3 with an ellipsoid transition zone volume of 20.1cm3. The median number of total TTMB cores was 58 with a median of 11 transition zone cores. Two hundred eighty-seven (63.2%) were diagnosed with prostate cancer. Transition zone cancer was detected in 130 (45.3%) of the patients with prostate cancer. Overall 38.9% of the transition zone cores were positive for malignancy. of the 130 transition zone cancers, 37 (28.5%), 64 (49.2%) and 29 (22.3%) were assigned Gleason score 6, 7, and 8-10 histology. Compared to a standard 12 core biopsy approach, the results of the transition zone biopsy upgraded the Gleason score in 24.6% of patients. of the 130 patients with transition zone cancer, only 4 (3.1%) were classified as clinically insignificant. Conclusions: Transperineal template guided mapping biopsy detects transition zone cancer in 45.3% of patients. Unlike brachytherapy, cryosurgery and HIFU must spare the periurethral region to preserve adequate urethral function and are unlikely to eradicate transition zone cancer in patients with such involvement. TTMB should be considered prior to any minimally invasive treatment, which spares the periurethral/transition zone region. Author Disclosure: V. Patel, None; G.S. Merrick, None; Z.A. Allen, None; W.M. Butler, None; E. Adamovich, None; K.E. Wallner, None.
170
RTOG 0537 Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) versus Pilocarpine in Treating Early Radiation-Induced Xerostomia (RIX): Phase II Results
R. K. Wong1, J. L. James2, S. Sagar1, G. Wyatt3, P. F. Nguyen-Tan4, A. K. Singh5, B. Lukaszczyk6, F. Cardinale7, A. M. Yeh8, L. Berk9 1
McMaster University, Juravinski Cancer Center, Hamilton, ON, Canada, 2RTOG Statistical Center, Philadelphia, PA, Michigan State University, East Lansing, MI, 4Centre Hospitalier de L’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 5Roswell Park Cancer Institute, Buffalo, NY, 6John H. Stroger, Jr. Hospital of Cook County MBCCOP, Chicago, IL, 7 Hospital of St. Raphael, New Haven, CT, 8Clarion Health Partners Inc., Indianapolis, IN, 9University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL 3
Purpose/Objective(s): Current treatment for RIX mainly relies on cholinergic agents with moderate side effects. A single institutional phase I/II study suggested ALTENS improves RIX with better xerostomia symptom scores and increased whole saliva production (WSP) with no significant side effects. We are examining ALTENS versus pilocarpine in treating RIX in a multicenter phase II/III randomized prospective study. Primary: Determine ALTENS treatment feasibility (delivered via the Codetron unit) in a cooperative group setting. Secondary: Evaluate ALTENS effect on xerostomia burden, as measured by the University of Michigan Xerostomia Related Quality of Life Scale at 6 months from registration (6 mth XeQOLS). Materials/Methods: Eligible patients (pts) had no evidence of recurrent disease and had completed, either standard or IMRT radiotherapy + chemotherapy (RT+C) $ 3 months to 2 years. All had grade 1-2 xerostomia (CTCAE v3.0) and had basal WSP $ 0.1 mL/min. Use of pilocarpine/cevimeline was discontinued .2 weeks prior to treatment. Pts were to receive twice weekly ALTENS sessions for a total of 24 (20 minutes) sessions over 12 weeks. Pts who completed $ 19 sessions were considered compliant.
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