Bicalutamide (150 mg) monotherapy versus LHRHa as neoadjuvant treatment in intermediate- and high-risk prostate cancer: A case matched study.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 226-226
Author(s):  
Darren M. Mitchell ◽  
Cliona McDowell ◽  
Ursula McGivern ◽  
Gemma Corey ◽  
Jolyne O'Hare ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Geometric Mean ◽  
Radical Radiotherapy ◽  
Psa Kinetics ◽  
High Risk Prostate Cancer ◽  
Significant Difference ◽  
Risk Prostate Cancer ◽  
Matched Study

226 Background: The role of neo-adjuvant Lutenising Hormone Releasing Hormone Agonist (LHRHa) therapy prior to radical radiotherapy of intermediate and high risk prostate cancer (PC) has been clearly defined. Anti-androgen (AA) monotherapy is often used as an alternative to castration therapy in this setting due to a more favorable toxicity profile, however the evidence base is weaker. We compared biochemical failure free survival (BFFS) and prostate-specific antigen (PSA) kinetics in men receiving radical radiotherapy for localised prostate cancer and neo-adjuvant hormones with either AA or LHRHa therapy. Methods: All men with intermediate and high risk PC treated with AA monotherapy prior to radical prostate radiotherapy between April 2004 and December 2008 were individually case matched for key prognostic factors with men treated with neoadjuvant LHRHa monotherapy at our institution. BFFS, PSA kinetics, and absolute pre-RT, post neo-adjuvant hormone PSA (PRPH-PSA) level were analyzed. Results: Sixty five men treated with AA monotherapy were matched to with 65 men treated with LHRHa. The median follow-up was 74 months and 67 months, respectively. Phoenix BFFS was seen in 14 (23.4%) and nine (13.8%) of AA and LHRHa patients respectively with the log rank test indicating no statistically significant difference between the groups. Statistically significant differences were seen between groups in the PRPH-PSA with a geometric mean of 2.0ng/ml (range 0.1 – 11.2) for AA patients and 1.0ng/ml (range 0.1 – 11.1) for LHRHa patients (p<0.001). There was no significant difference between groups in the geometric mean PSA halving time or velocity during the neo-adjuvant period. A PRPH-PSA of less than 1.0ng/ml and less than 0.1ng/ml was seen in 16 (24.6%) and two (3%) of the AA patients and 34 (52.3%) and three (4.6%) of LHRHa patients, respectively. Conclusions: Our case matched study demonstrates that there was no statistical difference in BFFS between patients receiving neo-adjuvant AA versus LHRHa at median follow-up of 72 months. AA monotherapy resulted in less PRPH-PSA suppression when compared to neo-adjuvant LHRHa alone. Longer follow-up is required to determine if the differences in PSA kinetics translate into clinically meaningful differences.

Single-fraction high-dose-rate (HDR) brachytherapy boost and hypofractionated radiation for intermediate- and high-risk prostate cancer: A report of toxicity from a single center experience.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 112-112
Author(s):  
Claire Arthur ◽  
Nooreen Sarah Alam ◽  
Paula Mandall ◽  
Ric Swindell ◽  
P. Anthony Elliott ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Dose Escalation ◽  
Hdr Brachytherapy ◽  
Single Fraction ◽  
Tumour Control ◽  
High Risk Prostate Cancer ◽  
Significant Difference ◽  
Risk Prostate Cancer

112 Background: Single-fraction HDR brachytherapy offers a highly conformal approach to dose escalation for intermediate and high risk prostate cancer and exploits the apparent low α/β ratio of prostate cancer cells. The potential benefit of improving tumour control must be balanced against the heightened risk of toxicity. We assessed and compared toxicity among patients receiving either 12.5 Gy or 15 Gy as a single fraction HDR boost prior to conformal external beam radiotherapy (EBRT). Methods: Between July 2008 and February 2011, 177 patients received HDR brachytherapy prior to conformal EBRT (37.5 Gy in 15 fractions). 95 patients in the early cohort received 12.5 Gy and 82 patients in the later cohort received 15 Gy. The median patient age at presentation was 67 (range 57 – 77) with a median PSA of 16.0 (range 0.29 – 102), median Gleason score 7 (range 6 – 10), clinical stages T1c to T4 and median baseline IPSS was 8 (range 0 – 27). Prospective patient questionnaires - IPSS, LENT SOMA and EPIC QoL - were completed prior to treatment and at regular intervals following EBRT (6 weeks, 6 monthly thereafter). Results: Both treatment groups had similar median IPSS values at 6 weeks (12.5 Gy = 10, 15 Gy = 11); there was no significant difference in values throughout follow-up. Mean LENT SOMA scores for bladder/urethra toxicity peaked at 6 weeks (12.5 Gy = 0.6, 15 Gy = 0.72) with no trend towards greater reporting of maximum values of ≥ 2 in the 15 Gy cohort. Rectum/bowel mean LENT SOMA scores peaked at 6 weeks (12.5 Gy = 0.30, 15 Gy = 0.39). Although a greater proportion of 15 Gy patients reported a maximum score of ≥ 2 at 6 weeks and 6 months compared with the 12.5 Gy patients, this returned to pre-treatment levels at 12 months. Conclusions: We conclude that dose escalation from 12.5 Gy to 15 Gy delivered in a single HDR fraction is not associated with a clinically significant increase in toxicity. We believe that the reported toxicity is acceptable at this level of dose escalation (2 Gy equivalent = 112 Gy, assuming an α/β ratio of 1.5). Ongoing follow-up is required to ascertain tumour control.

Neoadjuvant hormone therapy for radical prostate radiotherapy: A case-matched study comparing bicalutamide to LHRH agonist therapy.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 88-88
Author(s):  
Jolyne O'Hare ◽  
Ursula McGivern ◽  
Cliona McDowell ◽  
Darren M. Mitchell ◽  
Gemma Corey ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Geometric Mean ◽  
Treated Group ◽  
Biochemical Failure ◽  
Lhrh Agonist ◽  
Radical Radiotherapy ◽  
Agonist Therapy ◽  
Psa Kinetics ◽  
Matched Study

88 Background: To assess and compare the biochemical failure free survival (BFFS), PSA kinetics and absolute PSA responses in men receiving radical radiotherapy for localized prostate cancer (RT) receiving either neoadjuvant bicalutamide or neoadjuvant LHRH agonist therapy. Methods: A retrospective review of consecutive cases with prostate cancer treated with BC monotherapy prior to radical radiotherapy was individually case matched to men treated with neoadjuvant LHRHa monotherapy from April 2004 to December 2008. PSA kinetics and absolute pre-RT, post neo-adjuvant hormone PSA (PRPH-PSA) level and subsequent BFFS were analyzed. Results: 65 men treated with BC monotherapy were individually matched with 65 men treated with LHRHa. The median follow-up was 44 months and 54 months respectively. There were no significant differences in pre-treatment patient or tumour characteristics. Statistically significant differences were noted between groups in the PRPH-PSA with a geometric mean of 2.0ng/ml (range 0.1 – 11.2ng/ml) for BC patients and 1.0ng/ml (range 0.1 – 11.1ng/ml) for LHRHa patients (p<0.001). The geometric mean PSA halving time during the neo-adjuvant period of 14.6weeks (range 2 – 160weeks) in the BC treated group was statistically significantly different when compared to the mean of 16.1 weeks (range 2.1-96.8 weeks) for LHRHa patients (p=0.056). There were however no differences in PSA velocity. A PRPH-PSA of <1.0ng/ml and <0.1ng/ml was seen in 16(24.6%) and 2 (3%) of the BC patients and 34(52.3%) and 3(4.6%) of LHRHa patients respectively. Phoenix biochemical failure was seen in 10(15.4%, 95%CI [8.6%, 26.1%]) and 8(12.3%, [6.4%, 22.5%) of BC and LHRHa patients respectively. Neither PRPH-PSA level nor PSA kinetics during the neo-adjuvant period predict for subsequent BFFS at this duration of follow-up. Conclusions: In this case-matched study, we found that although neo-adjuvant BC therapy did not result in equivalent PRPH-PSA suppression when compared to neo-adjuvant LHRHa alone, there was no difference in biochemical failure rates between the cohorts at an overall median follow-up of 44 months. Longer follow-up is required.

Single institution, retrospective comparison of toxicity and outcome for static 5-field IMRT versus VMAT in the delivery of prostate and pelvic nodal irradiation in high-risk prostate cancer.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 147-147
Author(s):  
Philip Geoffrey Turner ◽  
Suneil Jain ◽  
Gemma Corey ◽  
Darren M. Mitchell ◽  
Karen Tumelty ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Outcome Data ◽  
Biochemical Failure ◽  
Single Institution ◽  
High Risk Prostate Cancer ◽  
Retrospective Comparison ◽  
Significant Difference ◽  
Risk Prostate Cancer

147 Background: There is emerging evidence for the role of pelvic nodal irradiation in high-risk prostate cancer. We have assessed the toxicity rates and outcomes with 2 different radiotherapy techniques. Methods: The baseline disease metrics, toxicity and outcome data for men treated at our institution with prostate and pelvic nodal irradiation during a 2 year period were retrospectively collected. The radiotherapy technique, either 5-field IMRT or VMAT was recorded along with a single dose-level to indicate normal tissue exposure (V50 to bowel and rectum, that is the percentage of total organ receiving ≥ 50Gy). Results: 67 men with a median age of 64 years were identified; 83.6% were Gleason ≥ 8, 82.1% were ≥ T3a, 50.7% were N1, 4.5% were M1a/M1b. All had neoadjuvant and concurrent hormone therapy. All received 74Gy to prostate; 70.1% received 60Gy to pelvic nodes, 28.4% received 55Gy to pelvic nodes (1 patient received 56Gy). 55.2% were treated with static IMRT and 44.8% with VMAT with no significant difference in nodal dose received by static vs VMAT groups. Median follow up was 25 months. Analysis found V50 rectum was significantly lower in those treated with VMAT compared to static IMRT (48.5% vs 54.76% p = 0.001). Acute bowel toxicity rates (RTOG grade) were 80.6% grade < 2, 19.4% grade 2, nil > grade 2. Late bowel toxicity rates (RTOG grade) were 88% grade < 2, 12% grade 2, nil > grade 2. There was no significant difference in rates of acute or late bowel toxicity in groups treated with static IMRT vs VMAT. 13 patients (19.4%) underwent lower GI endoscopy during follow up, 9 had radiation proctitis. There was no significant difference in rates of endoscopy or proctitis for VMAT vs IMRT groups. 11.9% of patients developed biochemical failure during follow up. Rates of biochemical failure were not significantly different in groups separated by dose to pelvic nodes or radiotherapy technique. Conclusions: In a single institution, retrospective analysis, prostate and pelvic nodal irradiation is associated with acceptable rates of toxicity. Treatment with VMAT is associated with a significantly lower V50 rectum than that delivered by static IMRT.

scholarly journals Observation with or without late radiotherapy is equivalent to early radiotherapy in high-risk prostate cancer after radical prostatectomy: A SEER-Medicare analysis on trends, survival outcomes and complications

2019 ◽  
Author(s):  
Young Suk Suk Kwon ◽  
Wei Wang ◽  
Arnav Srivast ◽  
Thomas L Jang ◽  
Singer A Eric ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Cox Regression ◽  
Survival Outcomes ◽  
Study Cohort ◽  
High Risk Prostate Cancer ◽  
Pathologic Features ◽  
Risk Prostate Cancer

Abstract Introduction: While early radiotherapy (eRT) after radical prostatectomy (RP) has shown to improve oncologic outcomes in patients with high-risk prostate cancer (PCa) in a recent clinical trial, controversy remains regarding its benefit. We aimed to illustrate national trends of post-RP radiotherapy and compare outcomes and toxicities in patients receiving eRT vs. observation with or without late radiotherapy (lRT). Methods: Utilizing the Surveillance, Epidemiology and End Results (SEER)-Medicare data from 2001 to 2011, we identified 7557 patients with high-risk pathologic features after RP (≥ pT3N0 and/or positive surgical margins). Our study cohort was consisted of patients receiving RT within 6 months of surgery (eRT), those receiving RT after 6 months (IRT), and those never receiving RT (observation). Another subcohort, delayed RT (dRT), encompassed both IRT and observation. Trends of post-RP radiotherapy were compared using the Cochran-Armitage trend test. Cox regression models identified factors predictive of worse survival outcomes. Kaplan-Meier analyses compared the eRT and the dRT groups. Results: Among those with pathologically confirmed high-risk PCa after RP, 12.7% (n=959), 13.2% (n=1710), and 74.1% (n=4888) underwent eRT, lRT, and observation without RT, respectively. Of these strategies, the proportion of men on observation without RT increased significantly over time (p=0.004). Multivariable Cox regression model demonstrated similar outcomes between the eRT and the dRT groups. At a median follow up of 5.9 years, five-year overall and cancer-specific survival outcomes were more favorable in the dRT group, when compared to the eRT group. Radiation related toxicities, including urinary incontinence, erectile dysfunction, and urethral stricture, were higher in the eRT group when compared to the lRT group. Conclusions: Our results suggest that a blanket adoption of the eRT in high-risk PCa based on clinical trials with limited follow up may result in overtreatment of a significant number of men and expose them to unnecessary radiation toxicity.

Quality of life in intermediate or high risk prostate cancer patients treated by 3-D external beam radiotherapy and brachytherapy with or without androgen deprivation

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14587-14587
Author(s):  
B. Guix ◽  
T. M. Lacorte ◽  
F. Guedea
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
High Risk ◽  
Sexual Function ◽  
External Beam Radiotherapy ◽  
External Beam ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

14587 Background: To elucidate long-term changes in health-related quality-of-life (HRQOL) outcomes by prospectively re-evaluating a cohort of intermediate- or high-risk prostate cancer patients treated by a combination of 3-D External Beam Radiotherapy (EBRT) and Brachytherapy (BT) with or without androgen deprivation (AD). Methods: A cross-sectional survey was administered to 200 consecutive patients with intermediate (Gleason 7 or PSA 10–20 or T2A-B) or high (Gleason >7 and/or PSA >20 and/or >T2B) - Risk Prostate cancer who were treated by EBRT to the prostate followed by BT to the prostate given either by permanent 125-I seeds (LDR) or high dose rate (HDR) implants before treatment and at 6 months interval during 4 years follow-up. The EORTC CLQ-C30 with the PR-25 module was employed. HRQOL was compared among therapy groups. Comparisons between therapy groups was performed using regression models to control covariates. HRQOL of treatment parameters were evaluated. Distribution of responses for bowel-, urinary- and sexual-related functions were analyzed. Results: 200 patients completed the questionnaires. Significant changes in HRQOL were found depending of the time after treatment. After a temporal decline in HRQOL, an improvement owas found during the first 18 months after end of treatment. Significant improvement in the urinary irritative-obstructive performance (p < 0.006) was found after 6 months post-treatment. Bowel domains worsened after therapies (p < 0,05) but improved after 18 months follow-up (p < 0.02). Overall sexual HRQOL deteriorated depending greatly on treatment (p < 0.008). Patients who were given AD presented a significant lower Sexual Function values, that were difficult to recover after AD cessation (p < 0.007). No differences in HRQOL were found between LDR or HDR BT implants. Satisfaction with either treatment was high. Conclusions: After a decline in HRQOL after treatment, it recovered fully during follow-up. In patients treated by AD, sexual function was the most adversely affected quality-of-life domain. Sexual impairment induced by AD was difficult to recover. These results may be of assistance to men and to clinicians when making treatment decisions, mainly relating AD. No significant financial relationships to disclose.

Adjuvant multimodality treatment in patients with high-risk prostate cancer following radical prostatectomy: Results of a prospective clinical phase-II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15557-15557
Author(s):  
D. Thüer ◽  
C. Ohlmann ◽  
D. Pfister ◽  
U. Engelmann ◽  
A. Heidenreich
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Phase Ii Trial ◽  
Multimodality Treatment ◽  
Time To Progression ◽  
Clinical Phase ◽  
High Risk Prostate Cancer ◽  
Psa Relapse ◽  
Risk Prostate Cancer

15557 Background: High risk prostate cancer (PCA) is associated with a high frequency of PSA relapse. Even with adjuvant androgen deprivation therapy about 50% of patients experience systemic recurrences within 5 years. Docetaxel has demonstrated significant activity in men with metastatic androgen independent PCA, zoledronic acid has been shown to significantly inhibit the development of osseous metastases. It was the aim of the current prospective clinical phase-II trial to evaluate safety and clinical efficacy of early multimodality treatment in high risk PCA after radical prostatectomy (RPE). Methods: Between 3/2004 and 12/2005 25 patients with high risk PCA following RPE were recruited. High risk PCA was defined by a risk of biochemical progression > 70% according to the postoperative Kattan nomograms. Adjuvant therapy consisted of androgen deprivation with LHRH analogues for 12 months, zoledronic acid at 4mg every 3 months and docetaxel at 75 mg/qm for six consecutive cycles. Adjuvant treatment was initiated 4 to 6 weeks after surgery. Follow-up examination were undertaken every 3 months with PSA serum determinations; in case of PSA increase 2 consecutive measurements at 4 weeks intervals were performed. Time to progression defined the time interval between initiation of therapy and first PSA relapse. Results: The mean follow-up is 20.5 (6–31) months. Adjuvant multimodality treatment was well tolerated in all patients with grade 3/4 hematotoxicity in 3 (12%) and gastrointestinal toxicity in 5 (16%) patients; 2 (8%) developed significant oncolysis with surgical intervention. In none of the patients the dosage of docetaxel or the number of cycles had to be reduced. Currently, 4 (16%) patients have developed PSA relapse with 2 exhibiting osseous metastases and 2 having died. Median time to progression was 14.5 (10–16) months. Conclusions: The clinical efficacy appears to be lower than expected with a 16% progression rate and a 8% mortality rate after only 20 months of follow-up. Adjuvant multimodality treatment of high risk PCA after RPE can be applied without significant treatment-associated side effects. Currently ongoing clinical phase-III trials have to further validate the concept of adjuvant chemotherapy. No significant financial relationships to disclose.

Duration of androgen deprivation therapy in high risk prostate cancer: Final results of a randomized phase III trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5008-5008 ◽  
Author(s):  
Abdenour Nabid ◽  
Marie-Pierre Garant ◽  
André-Guy Martin ◽  
Jean-Paul Bahary ◽  
Celine Lemaire ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Androgen Deprivation Therapy ◽  
Cox Regression ◽  
Mixed Linear Model ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
High Risk Prostate Cancer ◽  
Significant Difference ◽  
Risk Prostate Cancer

5008 Background: Long-term androgen deprivation therapy (ADT) combined with radiotherapy (RT) is a standard treatment for patients with high-risk prostate cancer (HRPC). However, the optimal duration of ADT is not yet defined. The aim of this randomized trial (Clinical Trials.gov, #NCT00223171) was to compare outcomes of RT combined with either 36 or 18 months of ADT. Methods: Patients with HRPC were randomized to pelvic and prostate RT combined with 36 (arm 1) or 18 months (arm 2) of ADT. Overall survival (OS) and quality of life (QoL) were primary end points. OS rates were compared with Cox Regression model and QoL data were analyzed through mixed linear model. Results: 630 patients were randomized, 310 to arm 1 and 320 to arm 2. With a median follow-up of 9.4 years, 290 patients had died (147 arm 1 vs. 143 arm 2). The 10-year OS rate was 62.4% (95% confidence interval [CI] 56.4%, 67.8%) for arm 1 and 62.0% (95% CI 56.1%, 67.3%) for arm 2 (p = 0.8412) with a global hazard ratio (HR) of 1.024 (95% CI 0.813-1.289, p = 0.8411). QoL analysis showed a significant difference (p < 0.001) in 6 scales and 13 items favoring 18 months ADT with two of them presenting a clinically relevant difference in mean scores of ≥10 points. Conclusions: In HRPC, ADT combined with RT can be safely reduced from 36 to 18 months without compromising outcomes or QoL. 18 months of ADT represents a new standard of care in HRPC. Funded by AstraZeneca Pharmaceuticals Clinical trial information: NCT00223171.

Association between primary surgery and all-cause mortality among elderly patients with high-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e576-e576
Author(s):  
Sumedha Chhatre ◽  
David Inkoo Lee ◽  
Doyeong Yu ◽  
S. Bruce Malkowicz ◽  
Ravishankar Jayadevappa
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
High Risk ◽  
Propensity Score ◽  
Curative Intent ◽  
High Risk Prostate Cancer ◽  
Primary Surgery ◽  
All Cause Mortality ◽  
Risk Prostate Cancer

e576 Background: To determine the five year survival impact of primary surgery compared to radiation therapy in older men with high risk prostate cancer. Methods: This was a population-based cohort study using Surveillance, Epidemiology, and End Results (SEER)-Medicare patients 66 years or older, diagnosed for prostate cancer between 2004 and 2008. High-risk prostate cancer was identified as Gleason score of ≥ 8, or clinical stage T3a. Treatments studied were definitive local (curative intent) therapy (surgery or radiation therapy) within 180 days of prostate cancer diagnosis. The two treatment groups were retrospectively followed for one-year pre and five years post diagnosis. Main outcome measure was five-year all-cause mortality and cancer specific mortality. Sequential Cox regression was used to assess the hazard of mortality associated with surgery, compared to radiation therapy, after adjusting for socio-demographic variables, variables and propensity score. Results: We identified a cohort of 24,838 men newly diagnosed for high-risk for prostate cancer between 2004 and 2008. Forty-seven percent of these had surgery (n = 11,696) as well as radiation therapy (n = 11,724) as a primary treatment with curative intent within 180 days of diagnosis. Mean age at diagnosis of radiation therapy group was higher compared to surgery group (73.5, sd = 5.3 vs. 70.3, sd = 4.9; p = 0.020). Radiation group had higher comorbidity compared to surgery group (37% vs. 26%, p = 0.0316). Unadjusted all-cause mortality comparison over five years of follow-up showed that surgery treatment was associated with lower mortality (HR = 0.58, CI = 0.54, 0.62). After adjusting for propensity score, the hazard of all-cause five year mortality remained lower for surgery compared to radiation therapy (HR = 0.86, CI = 0.78, 9.4). Conclusions: Over a five-year follow-up, primary surgery was associated with improved survival compared to radiation therapy in high-risk prostate cancer patients. Longer follow-up is needed to determine if the survival advantage of surgery will persist as well as factors contributing to the difference in survival.

Stereotactic pelvic radiotherapy with HDR boost for dose escalation in intermediate and high-risk prostate cancer (SPARE): Efficacy, survival, and late toxicity outcomes.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 328-328
Author(s):  
Andrew Loblaw ◽  
Bindu Musunuru ◽  
Patrick Cheung ◽  
Danny Vesprini ◽  
Stanley K. Liu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Treatment Protocol ◽  
Late Toxicity ◽  
Hdr Brachytherapy ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Brachytherapy Boost

328 Background: The ASCO/CCO guidelines recommend brachytherapy boost for all eligible intermediate- or high-risk localized prostate cancer patients. We present efficacy, survival and late toxicity outcomes in patients treated on a prospective, single institutional protocol of MRI dose painted HDR brachytherapy boost (HDR-BT) followed by pelvic stereotactic body radiotherapy (SBRT) and androgen deprivation therapy (ADT). Methods: A phase I/II study was performed where intermediate (IR) or high-risk (HR) prostate cancer patients received HDR-BT 15Gy x 1 to the prostate and up to 22.5Gy to the MRI nodule and followed by gantry-based SBRT 25Gy in 5 weekly fractions delivered to pelvis, seminal vesicles and prostate. ADT was used for 6-18 months. CTCAEv3 was used to assess toxicities and was captured q6months x 5 years. Biochemical failure (BF; nadir + 2 definition), nadir PSA, proportion of patients with PSA < 0.4 ng/ml at 4 years (4yPSARR), incidence of salvage therapy, cause specific survival and overall survival were calculated. Day 0 was HDR-BT date for all time-to-event analyses. Results: Thirty-two patients (NCCN 3% favorable IR, 47% unfavorable IR and 50% HR) completed the planned treatment with a median follow-up of 50 months; 31 of these had an MRI nodule. Four patients had BF with actuarial 4-year BF rate of 11.5%; 3 of these received salvage ADT. Median nPSA was 0.02 ng/ml; 4yPSARR was 68.8%. One patient died (of prostate cancer) at 45 months. For late toxicities, grade 1, 2 and 3+ GU and GI toxicities were: 40.6%, 37.5%, 3% and 28.1%, 0%, 0%, respectively. Conclusions: This novel treatment protocol incorporating MRI-dose painted HDR brachytherapy boost and SBRT pelvic radiation for intermediate- and high-risk prostate cancer in combination with ADT is feasible, effective and well tolerated. Clinical trial information: 12345678. [Table: see text]

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