- Email: [email protected]
Long Term Results of a Phase II Trial of Ultrasound-guided Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate (RTOG 98–05)
I. J. Radiation Oncology d Biology d Physics
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Volume 75, Number 3, Supplement, 2009
wall receiving doses ranging from 25 to 80 CGE. Of the 10 patients developing GR 2 or higher GI symptoms at 6 or 12 months, 5 originally had GR 1 that progressed to GR 2 or 3 after a colonoscopic intervention. In a subset of 35 patients judged appropriate for brachytherapy (low risk, prostate size\60 cc, IPSS\15, and no prior GU symptom management), the 6- and 12-month rates of GR 2 GU toxicities were 17% and 9%, respectively; there were no GR 3 GU toxicities and no GR 2 or higher GI toxicities. Conclusions: Early GU and GI toxicity on prospective trials of proton therapy has been minimal with GR 3 GU and GI toxicities at \1% and \0.5%, respectively. Early GU symptoms were associated with pretreatment conditions. Early GI toxicity was associated with the percentage of rectal wall receiving a range of doses from 25 CGE to 80 CGE, but was also significantly impacted by post-treatment colonoscopy interventions. Author Disclosure: N.P. Mendenhall, None; Z. Li, None; C.G. Morris, None; C.R. Williams, None; J.A. Costa, None; B. Hoppe, None; R. Marcus, None; W.M. Mendenhall, None; R.C. Nichols, None; R. Henderson, None.
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Vessel Sparing Radiotherapy for Prostate Cancer: Clinical Results with a Minimum of 2-year Follow-up
W. McLaughlin, C. Evans, V. Narayana University of Michigan, Ann Arbor, MI Purpose/Objective(s): We have previously defined a method to spare critical erectile structures (CES), including prostate apex definition by coronal MRI, internal pudendal artery (IPA) by time of flight MRI sequence, and penile bulb (PB) and corpus cavernosum (CC) by T2 MRI. We report the outcomes in beam alone and combination beam and LDR boost patients with a minimum of 2 years follow-up. Materials/Methods: Ninety patients with baseline normal erectile function were treated on a vessel- and CES-sparing protocol employing CT fused to axial, sagittal, and coronal MRI, and time of flight MRI angiogram. Thirty beam-only patients were treated to a 0.5 mm prostate expansion by 3D conformal or IMRT plans to 75.8–80 Gy. Sixty combination patients were treated with implant before or after beam radiation to an average dose of 90 Gy external beam equivalent. All patients had MRI definition of the prostate and CES. The prostate target received full dose and prostate coverage was never compromised to achieve CES-sparing. The CES dose was defined by dose to 10% (D10), dose to 50% (D50), and dose to 90% (D90) of PB, CC, IPA, and NVB. The International Index of Erectile Function (IIEF-5) instrument was used at baseline and annually to assess erectile function and was scored separately for function with and without phosphodiesterase 5 inhibitors (PDEI). Any IIEF \16 was the cutoff for profound erectile dysfunction (ED). Any IIEF 21–25 defined the no ED category, 16 to 20 defined minimal ED. No patients received hormone therapy and no patients used PDEI at baseline. Results: For all patients with a baseline IIEF5 .16, the 2 year potency rate was 60.6% without (PDEI-) and 73.0% with (PDEI+) medications, and 4 year results were 56.7% (PDEI-) and 70.0% (PDEI+). No statistically significant difference was noted between 2 and 4 years or between beam and combination. There was no difference in IIEF baseline by age (\60, 60–70, and .70) but a significant difference (p # 0.02) was noted by age in outcomes, with potency preservation without medications in 81% of age \60, 59% in age 60–70, and 48% in age .70. Doses to CES varied widely. There was no correlation of treatment failure with dose to PB, CC, IPA, or NVB. The NVB dose was consistently higher in the combination group, while dose to PB, CC, and IPA was consistently lower in combination patients vs. beam. Conclusions: The ED rates reported here are among the lowest in the literature for patients treated with beam or combination therapy and monitored in prospective fashion with a validated ED instrument. Any ED at 4 years did not differ from ED at 2 years, and ED postaggressive combined modality did not differ from ED post beam. Although vessel-sparing therapy was successful clinically, no single target or dose to CES correlated with ED postradiation. Radiation-induced ED appears to be a complex, multifactorial process with vulnerability determined by age. Author Disclosure: W. McLaughlin, None; C. Evans, None; V. Narayana, None.
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Long Term Results of a Phase II Trial of Ultrasound-guided Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate (RTOG 98–05)
C. A. Lawton1, D. Hunt2, W. R. Lee3, L. Gomella4, D. Grignon5, M. Gillin6, G. Morton7, T. Pisansky8, H. Sandler9 1 Medical College of Wisconsin, Milwaukee, WI, 2Radiation Therapy Oncology Group, Philadelphia, PA, 3Duke University School of Medicine, Durham, NC, 4Thomas Jefferson University, Philadelphia, PA, 5University of Indiana, Indianapolis, IN, 6M. D. Anderson, Houston, TX, 7Toronto-Sunnybrook Regional Cancer Center, Toronto, ON, Canada, 8Mayo Clinic, Rochester, MN, 9University of Michigan, Ann Arbor, MI
Purpose/Objective(s): To evaluate the long-term effectiveness of permanent radioactive I–125 implantation of the prostate for organ-confined adenocarcinoma of the prostate compared with historic data of prostatectomy and external radiation within a cooperative group setting. Materials/Methods: Patients accrued to this study had histologically-confirmed, locally confined, adenocarcinoma of the prostate with clinical Stages #T2a, PSA #10 ng/mL, and GS #6. All patients underwent radioactive I–125 permanent seed implantation. The prescribed dose was 145 Gy to the prostate planning target volume. Late toxicity is defined as that occurring $9 months postimplant and was reported using the RTOG late toxicity scoring criteria. The Kaplan-Meier method was used to estimate overall survival (OS) and the cumulative incidence approach used to estimate all other failure types (biochemical, local, and distant) and late toxicity. Results: A total of 101 patients from 27 institutions were accrued to this protocol; by design, no single institution accrued .8 patients. There were 94 eligible patients. The median follow-up was 8.1 years (range, 0.1–9.2 years). After 8 years, 8 patients had protocol-defined biochemical failure, 5 patients had local failure, and 1 patient had distant failure; this patient also had biochemical failure and a nonprostate cancer-related death. The 8-year OS rate was 88%. At last follow-up, no patient died of prostate cancer or related toxicities. Three patients had a maximum late toxicity of Grade 3. No Grade 4 or 5 toxicities were observed.
Proceedings of the 51st Annual ASTRO Meeting Conclusions: The long-term results of this clinical protocol have demonstrated that this type of trial can be successfully completed through the RTOG and that the results in terms of biochemical failure and toxicity compare very favorably with other brachytherapy published series as well as surgical and external beam radiotherapy series. Additionally, the prospective multicenter design highlights the probable generalizability of the outcomes. Supported by grant numbers (RTOG U10 CA21661, CCOP U10 CA37422) from the National Cancer Institute. Author Disclosure: C.A. Lawton, None; D. Hunt, None; W.R. Lee, None; L. Gomella, None; D. Grignon, None; M. Gillin, None; G. Morton, None; T. Pisansky, None; H. Sandler, None.
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Phase I Study of Preoperative Radiation and Docetaxel for High-risk Prostate Cancer
M. Garzotto1,2, A. Hung1, T. M. Beer1, P. Farris1,2 1
Oregon Health and Science University, Portland, OR, 2Portland VA Medical Center, Portland, OR
Purpose/Objective(s): Trials of adjuvant and salvage radiation for high-risk prostate cancer demonstrate that the incidence of local recurrence after prostatectomy is a common occurrence. Preoperative chemoradiation has the potential to reduce local recurrences and improve survival, but has not been studied in prostate cancer. The establishment of a preprostatectomy model that includes radiation would facilitate the discovery of novel mechanisms of radio-resistance. The objective of this trial was to evaluate the feasibility and safety of preoperative radiation and docetaxel prior to prostatectomy. Initial pathologic and PSA outcomes were reviewed. Materials/Methods: Eligible patients had: (1) cT2b or resectable cT3a prostate cancer, (2) a serum PSA $15 ng/mL, or (3) a primary Gleason Grade $4. All patients received 45 Gy over 25 fractions to the prostate and seminal vesicles with IMRT. Escalating doses of weekly docetaxel were given for 5 consecutive weeks during IMRT. Three patients were accrued at each dose level of 0 mg/m2, 10 mg/m2, 20 mg/m2, and 30 mg/m2. The dose escalation continued to a planned dose of 30 mg/m2 or until 1 or more patients per cohort experienced a DLT, defined as greater than Grade 3 nonhematologic (excluding hyperglycemia) or Grade 4 hematologic toxicity. Results: Twelve patients were accrued between April 2006 and March 2008. All planned treatments were administered. The maximum planned dose of 30 mg/m2 was reached without DLTs. There were three Grade 3 toxicities in three different men (lymphopenia, hyperglycemia, and low hemoglobin). Grade 4 hyperglycemia occurred in 1 patient. There were no DVTs, rectal or ureteral injuries. Pathologic staging was: T2 - 9 patients, T3 - 3 patients, and node positive - 3 patients. Surgical margins were negative in 75% of cases. Post-op PSA levels were undetectable (\0.1 ng/mL) in all patients. Conclusions: Preoperative radiation and docetaxel before prostatectomy is feasible with acceptable toxicity. Based on these findings, a Phase II study continuing with IMRT to 45 Gy and 30 mg/m2 docetaxel weekly for 5 weeks has been initiated. Additional studies are needed to determine whether this combined modality approach will reduce cancer recurrence rates in this high-risk population. Author Disclosure: M. Garzotto, Sanofi-Aventis, B. Research Grant; A. Hung, None; T.M. Beer, Sanofi-Aventis, B. Research Grant; P. Farris, None.
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Prospective Study Evaluating Salvage Radiotherapy Plus 2-year Androgen Suppression for Post-radical Prostatectomy Patients with PSA Relapse
C. Choo1, C. Danjoux2, S. Gardner2, G. Morton2, E. Szumacher2, A. Loblaw2, P. Cheung2, M. Pearse3 1
Mayo Clinic, Rochester, MN, 2Odette Cancer Center, Toronto, ON, Canada, 3Auckland Hospital, Auckland, New Zealand
Purpose/Objective(s): To determine the efficacy of a combined approach of salvage radiotherapy (RT) plus 2-year androgen suppression (AS) for patients with PSA relapse after radical prostatectomy (RP). Materials/Methods: A total of 75 patients with PSA relapse after RP were treated with RT plus 2-year AS, as per a Phase I/II study. Patients were assigned into two groups: group 1: PSA relapse alone after initially undetectable postoperative PSA, and group 2: PSA relapse with clinically palpable or biopsy-proven local recurrence. The AS started within 1 month after RT, and consisted of nilutamide for 4 weeks and buserelin acetate depot every 2 months for 2 years. Relapse-free rate including freedom from PSA relapse was estimated using the Kaplan-Meier method. The PSA relapse was defined as a rise above 0.2 ng/mL with two consecutive increases over a minimum of 3 months. A Cox regression analysis was performed to evaluate prognostic factors for relapse. Results: Median age was 63-years-old at the time of salvage RT. Median follow-up from RT was 6.4-years-old. A total of 49 patients were in group 1 and 26 in group 2. Median interval between RP and RT was 36 months. Median RT dose was 66 Gy for both groups with 2 Gy/fraction. Sixty-five patients completed 2-year AS, while 10 had a shorter AS (median: 19 months). Distribution of Gleason score was: 5:6:7:8–10 = 3%:16%:67%:15%. A total of 60% had pT2, 23% with pT3a, and 17% with pT3b. Fifty-seven percent had positive surgical margins. Median PSA before RT was 0.9. Group 2 (vs. group 1) had a higher median PSA before RT (1.7 vs. 0.7) and a higher rate of positive margins (81% vs. 45%). All achieved undetectable PSA with the protocol treatment. Relapse-free rate including freedom from PSA relapse was 92% at 5 years and 79% at 7 years. Relapse-free rate was similar between group 1 and group 2 (81% vs. 76% at 7 years). Survival rate was 93% at both 5 and 7 years. At the last follow-up, 13 (including 2 with distant metastasis) had PSA relapse (8 in group 1 and 5 in group 2). None had local recurrence. Five died (including 2 from prostate cancer). The pT3 and PSA relapse\2 years after RP were significant prognostic factors for relapse. Cumulative incidences of Grade $2 and 3 late GI morbidity at 3 years were 8.7% and 1.6%, respectively, using NCI Expanded Common Toxicity Criteria version 2; 22.6% and 2.8% for Grade $2, and 3 late GU morbidity, respectively, at 3 years. Conclusions: The combined treatment of salvage RT plus 2-year AS yielded an encouraging result for patients with PSA relapse after RP. A confirmatory study is needed. Author Disclosure: C. Choo, Educational grant from Aventis Pharma Inc., C. Other Research Support; C. Danjoux, None; S. Gardner, None; G. Morton, None; E. Szumacher, None; A. Loblaw, None; P. Cheung, None; M. Pearse, None.
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Volume 75, Number 3, Supplement, 2009
wall receiving doses ranging from 25 to 80 CGE. Of the 10 patients developing GR 2 or higher GI symptoms at 6 or 12 months, 5 originally had GR 1 that progressed to GR 2 or 3 after a colonoscopic intervention. In a subset of 35 patients judged appropriate for brachytherapy (low risk, prostate size\60 cc, IPSS\15, and no prior GU symptom management), the 6- and 12-month rates of GR 2 GU toxicities were 17% and 9%, respectively; there were no GR 3 GU toxicities and no GR 2 or higher GI toxicities. Conclusions: Early GU and GI toxicity on prospective trials of proton therapy has been minimal with GR 3 GU and GI toxicities at \1% and \0.5%, respectively. Early GU symptoms were associated with pretreatment conditions. Early GI toxicity was associated with the percentage of rectal wall receiving a range of doses from 25 CGE to 80 CGE, but was also significantly impacted by post-treatment colonoscopy interventions. Author Disclosure: N.P. Mendenhall, None; Z. Li, None; C.G. Morris, None; C.R. Williams, None; J.A. Costa, None; B. Hoppe, None; R. Marcus, None; W.M. Mendenhall, None; R.C. Nichols, None; R. Henderson, None.
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Vessel Sparing Radiotherapy for Prostate Cancer: Clinical Results with a Minimum of 2-year Follow-up
W. McLaughlin, C. Evans, V. Narayana University of Michigan, Ann Arbor, MI Purpose/Objective(s): We have previously defined a method to spare critical erectile structures (CES), including prostate apex definition by coronal MRI, internal pudendal artery (IPA) by time of flight MRI sequence, and penile bulb (PB) and corpus cavernosum (CC) by T2 MRI. We report the outcomes in beam alone and combination beam and LDR boost patients with a minimum of 2 years follow-up. Materials/Methods: Ninety patients with baseline normal erectile function were treated on a vessel- and CES-sparing protocol employing CT fused to axial, sagittal, and coronal MRI, and time of flight MRI angiogram. Thirty beam-only patients were treated to a 0.5 mm prostate expansion by 3D conformal or IMRT plans to 75.8–80 Gy. Sixty combination patients were treated with implant before or after beam radiation to an average dose of 90 Gy external beam equivalent. All patients had MRI definition of the prostate and CES. The prostate target received full dose and prostate coverage was never compromised to achieve CES-sparing. The CES dose was defined by dose to 10% (D10), dose to 50% (D50), and dose to 90% (D90) of PB, CC, IPA, and NVB. The International Index of Erectile Function (IIEF-5) instrument was used at baseline and annually to assess erectile function and was scored separately for function with and without phosphodiesterase 5 inhibitors (PDEI). Any IIEF \16 was the cutoff for profound erectile dysfunction (ED). Any IIEF 21–25 defined the no ED category, 16 to 20 defined minimal ED. No patients received hormone therapy and no patients used PDEI at baseline. Results: For all patients with a baseline IIEF5 .16, the 2 year potency rate was 60.6% without (PDEI-) and 73.0% with (PDEI+) medications, and 4 year results were 56.7% (PDEI-) and 70.0% (PDEI+). No statistically significant difference was noted between 2 and 4 years or between beam and combination. There was no difference in IIEF baseline by age (\60, 60–70, and .70) but a significant difference (p # 0.02) was noted by age in outcomes, with potency preservation without medications in 81% of age \60, 59% in age 60–70, and 48% in age .70. Doses to CES varied widely. There was no correlation of treatment failure with dose to PB, CC, IPA, or NVB. The NVB dose was consistently higher in the combination group, while dose to PB, CC, and IPA was consistently lower in combination patients vs. beam. Conclusions: The ED rates reported here are among the lowest in the literature for patients treated with beam or combination therapy and monitored in prospective fashion with a validated ED instrument. Any ED at 4 years did not differ from ED at 2 years, and ED postaggressive combined modality did not differ from ED post beam. Although vessel-sparing therapy was successful clinically, no single target or dose to CES correlated with ED postradiation. Radiation-induced ED appears to be a complex, multifactorial process with vulnerability determined by age. Author Disclosure: W. McLaughlin, None; C. Evans, None; V. Narayana, None.
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Long Term Results of a Phase II Trial of Ultrasound-guided Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate (RTOG 98–05)
C. A. Lawton1, D. Hunt2, W. R. Lee3, L. Gomella4, D. Grignon5, M. Gillin6, G. Morton7, T. Pisansky8, H. Sandler9 1 Medical College of Wisconsin, Milwaukee, WI, 2Radiation Therapy Oncology Group, Philadelphia, PA, 3Duke University School of Medicine, Durham, NC, 4Thomas Jefferson University, Philadelphia, PA, 5University of Indiana, Indianapolis, IN, 6M. D. Anderson, Houston, TX, 7Toronto-Sunnybrook Regional Cancer Center, Toronto, ON, Canada, 8Mayo Clinic, Rochester, MN, 9University of Michigan, Ann Arbor, MI
Purpose/Objective(s): To evaluate the long-term effectiveness of permanent radioactive I–125 implantation of the prostate for organ-confined adenocarcinoma of the prostate compared with historic data of prostatectomy and external radiation within a cooperative group setting. Materials/Methods: Patients accrued to this study had histologically-confirmed, locally confined, adenocarcinoma of the prostate with clinical Stages #T2a, PSA #10 ng/mL, and GS #6. All patients underwent radioactive I–125 permanent seed implantation. The prescribed dose was 145 Gy to the prostate planning target volume. Late toxicity is defined as that occurring $9 months postimplant and was reported using the RTOG late toxicity scoring criteria. The Kaplan-Meier method was used to estimate overall survival (OS) and the cumulative incidence approach used to estimate all other failure types (biochemical, local, and distant) and late toxicity. Results: A total of 101 patients from 27 institutions were accrued to this protocol; by design, no single institution accrued .8 patients. There were 94 eligible patients. The median follow-up was 8.1 years (range, 0.1–9.2 years). After 8 years, 8 patients had protocol-defined biochemical failure, 5 patients had local failure, and 1 patient had distant failure; this patient also had biochemical failure and a nonprostate cancer-related death. The 8-year OS rate was 88%. At last follow-up, no patient died of prostate cancer or related toxicities. Three patients had a maximum late toxicity of Grade 3. No Grade 4 or 5 toxicities were observed.
Proceedings of the 51st Annual ASTRO Meeting Conclusions: The long-term results of this clinical protocol have demonstrated that this type of trial can be successfully completed through the RTOG and that the results in terms of biochemical failure and toxicity compare very favorably with other brachytherapy published series as well as surgical and external beam radiotherapy series. Additionally, the prospective multicenter design highlights the probable generalizability of the outcomes. Supported by grant numbers (RTOG U10 CA21661, CCOP U10 CA37422) from the National Cancer Institute. Author Disclosure: C.A. Lawton, None; D. Hunt, None; W.R. Lee, None; L. Gomella, None; D. Grignon, None; M. Gillin, None; G. Morton, None; T. Pisansky, None; H. Sandler, None.
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Phase I Study of Preoperative Radiation and Docetaxel for High-risk Prostate Cancer
M. Garzotto1,2, A. Hung1, T. M. Beer1, P. Farris1,2 1
Oregon Health and Science University, Portland, OR, 2Portland VA Medical Center, Portland, OR
Purpose/Objective(s): Trials of adjuvant and salvage radiation for high-risk prostate cancer demonstrate that the incidence of local recurrence after prostatectomy is a common occurrence. Preoperative chemoradiation has the potential to reduce local recurrences and improve survival, but has not been studied in prostate cancer. The establishment of a preprostatectomy model that includes radiation would facilitate the discovery of novel mechanisms of radio-resistance. The objective of this trial was to evaluate the feasibility and safety of preoperative radiation and docetaxel prior to prostatectomy. Initial pathologic and PSA outcomes were reviewed. Materials/Methods: Eligible patients had: (1) cT2b or resectable cT3a prostate cancer, (2) a serum PSA $15 ng/mL, or (3) a primary Gleason Grade $4. All patients received 45 Gy over 25 fractions to the prostate and seminal vesicles with IMRT. Escalating doses of weekly docetaxel were given for 5 consecutive weeks during IMRT. Three patients were accrued at each dose level of 0 mg/m2, 10 mg/m2, 20 mg/m2, and 30 mg/m2. The dose escalation continued to a planned dose of 30 mg/m2 or until 1 or more patients per cohort experienced a DLT, defined as greater than Grade 3 nonhematologic (excluding hyperglycemia) or Grade 4 hematologic toxicity. Results: Twelve patients were accrued between April 2006 and March 2008. All planned treatments were administered. The maximum planned dose of 30 mg/m2 was reached without DLTs. There were three Grade 3 toxicities in three different men (lymphopenia, hyperglycemia, and low hemoglobin). Grade 4 hyperglycemia occurred in 1 patient. There were no DVTs, rectal or ureteral injuries. Pathologic staging was: T2 - 9 patients, T3 - 3 patients, and node positive - 3 patients. Surgical margins were negative in 75% of cases. Post-op PSA levels were undetectable (\0.1 ng/mL) in all patients. Conclusions: Preoperative radiation and docetaxel before prostatectomy is feasible with acceptable toxicity. Based on these findings, a Phase II study continuing with IMRT to 45 Gy and 30 mg/m2 docetaxel weekly for 5 weeks has been initiated. Additional studies are needed to determine whether this combined modality approach will reduce cancer recurrence rates in this high-risk population. Author Disclosure: M. Garzotto, Sanofi-Aventis, B. Research Grant; A. Hung, None; T.M. Beer, Sanofi-Aventis, B. Research Grant; P. Farris, None.
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Prospective Study Evaluating Salvage Radiotherapy Plus 2-year Androgen Suppression for Post-radical Prostatectomy Patients with PSA Relapse
C. Choo1, C. Danjoux2, S. Gardner2, G. Morton2, E. Szumacher2, A. Loblaw2, P. Cheung2, M. Pearse3 1
Mayo Clinic, Rochester, MN, 2Odette Cancer Center, Toronto, ON, Canada, 3Auckland Hospital, Auckland, New Zealand
Purpose/Objective(s): To determine the efficacy of a combined approach of salvage radiotherapy (RT) plus 2-year androgen suppression (AS) for patients with PSA relapse after radical prostatectomy (RP). Materials/Methods: A total of 75 patients with PSA relapse after RP were treated with RT plus 2-year AS, as per a Phase I/II study. Patients were assigned into two groups: group 1: PSA relapse alone after initially undetectable postoperative PSA, and group 2: PSA relapse with clinically palpable or biopsy-proven local recurrence. The AS started within 1 month after RT, and consisted of nilutamide for 4 weeks and buserelin acetate depot every 2 months for 2 years. Relapse-free rate including freedom from PSA relapse was estimated using the Kaplan-Meier method. The PSA relapse was defined as a rise above 0.2 ng/mL with two consecutive increases over a minimum of 3 months. A Cox regression analysis was performed to evaluate prognostic factors for relapse. Results: Median age was 63-years-old at the time of salvage RT. Median follow-up from RT was 6.4-years-old. A total of 49 patients were in group 1 and 26 in group 2. Median interval between RP and RT was 36 months. Median RT dose was 66 Gy for both groups with 2 Gy/fraction. Sixty-five patients completed 2-year AS, while 10 had a shorter AS (median: 19 months). Distribution of Gleason score was: 5:6:7:8–10 = 3%:16%:67%:15%. A total of 60% had pT2, 23% with pT3a, and 17% with pT3b. Fifty-seven percent had positive surgical margins. Median PSA before RT was 0.9. Group 2 (vs. group 1) had a higher median PSA before RT (1.7 vs. 0.7) and a higher rate of positive margins (81% vs. 45%). All achieved undetectable PSA with the protocol treatment. Relapse-free rate including freedom from PSA relapse was 92% at 5 years and 79% at 7 years. Relapse-free rate was similar between group 1 and group 2 (81% vs. 76% at 7 years). Survival rate was 93% at both 5 and 7 years. At the last follow-up, 13 (including 2 with distant metastasis) had PSA relapse (8 in group 1 and 5 in group 2). None had local recurrence. Five died (including 2 from prostate cancer). The pT3 and PSA relapse\2 years after RP were significant prognostic factors for relapse. Cumulative incidences of Grade $2 and 3 late GI morbidity at 3 years were 8.7% and 1.6%, respectively, using NCI Expanded Common Toxicity Criteria version 2; 22.6% and 2.8% for Grade $2, and 3 late GU morbidity, respectively, at 3 years. Conclusions: The combined treatment of salvage RT plus 2-year AS yielded an encouraging result for patients with PSA relapse after RP. A confirmatory study is needed. Author Disclosure: C. Choo, Educational grant from Aventis Pharma Inc., C. Other Research Support; C. Danjoux, None; S. Gardner, None; G. Morton, None; E. Szumacher, None; A. Loblaw, None; P. Cheung, None; M. Pearse, None.
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