scholarly journals Non-Adaptive MR-Guided Radiotherapy for Prostate SBRT: Less Time, Equal Results

2021 ◽  
Vol 10 (15) ◽  
pp. 3396
Author(s):  
Maria L. Sandoval ◽  
Irini Youssef ◽  
Kujtim Latifi ◽  
G. Daniel Grass ◽  
Javier Torres-Roca ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Symptom Score ◽  
Prostate Gland ◽  
Topical Steroids ◽  
Intermediate Risk ◽  
Adaptive Planning ◽  
Require Time ◽  
Pre Treatment ◽  
Time Required

Background: The use of stereotactic body radiation therapy (SBRT) is widely utilized for treatment of localized prostate cancer. Magnetic-resonance-guided radiotherapy (MRgRT) was introduced in 2014 and has recently been implemented in SBRT for prostate cancer as it provides an opportunity for smaller margins and adaptive daily planning. Currently, the only publications of MRgRT for prostate SBRT describe European clinical experiences which utilized adaptive planning. However, adaptive planning adds significantly to the time required for daily treatment. Objectives: Since prostate SBRT has demonstrated acceptable toxicity for several years, we did not consider daily adaptation critical to the process of prostate SBRT. After Institutional Review Board approval, we analyzed and now report our experience using MRgRT without adaptation. Methods: Between 25 September 2019 and 21 December 2020, 35 consecutive patients were treated with MRgRT prostate SBRT at our center. Patients treated with MRgRT included favorable intermediate risk (43%) and unfavorable intermediate risk (54%), and only one patient had low-risk prostate cancer. Nine patients (25%) received adjuvant leuprolide for a median of 4.5 months (range 4–6 m). Our clinical pathway allows for a maximum prostate gland volume of 60 cc; median prostate volume of this cohort was 35.0 cc (range 17–58.4 cc). Median pre-treatment PSA was 6.30 (range 2.55–16.77). Each patient was treated with 36.25 Gy delivered in five fractions over 2 weeks with urethral sparing to a maximal dose of 35 Gy. Target volumes included the prostate gland and proximal seminal vesicles with a 3 mm margin. Results: Median follow-up as of 26 May 2021 was 11.97 months (range 4.37–19.80). First follow-up data are available for all patients, with a median of 1.10 month from completion of treatment (0.63–3.40). The median PSA at first visit was 2.75 (range 0.02–9.00) with a median AUA symptom score of 9 (range 1–24). Second follow-up data are available for 34 patients at a median of 4.45 months (range 2.57–8.90). At second follow-up, the median PSA was 1.60 (range 0.02–5.40) with a median AUA symptom score of 6 (range 1–33). Seventeen patients had third follow-up data with a median of 9.77 months (range 4.70–12.33) after SBRT. The median PSA was 1.13 (range 0.02–4.73) with an AUA score of 9 (2–22) at the third follow-up. We observed a statistically significant decrease in PSA between pre-treatment and at first follow-up (p < 0.005). The most common toxicity was grade 2 urethritis, managed in all cases by tamsulosin. One patient developed grade 2 tenesmus relieved by topical steroids. No cases of grade ≥ 3 toxicity were seen in our patient population. Conclusions: By avoiding the extra time required for plan adaptation, MRgRT without daily adaptation allows for successful prostate SBRT with manageable toxicity. We continue to reserve our limited adaptive treatment slots for preoperative pancreatic and ultra-central lung SBRT patients, which require time-intensive respiratory gating and adaptive planning.

Adverse pathology as a predictor of distant metastasis and prostate cancer mortality with 20-year follow up.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 219-219
Author(s):  
Michael Austin Brooks ◽  
Lewis Thomas ◽  
Cristina Magi-Galluzi ◽  
Jianbo Li ◽  
Michael Crager ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Active Surveillance ◽  
Distant Metastasis ◽  
Cancer Mortality ◽  
High Grade ◽  
Intermediate Risk ◽  
Sampling Weights ◽  
Prostate Cancer Mortality

219 Background: Adverse pathology (AP) at radical prostatectomy (RP) is often used as a proxy for long-term prostate cancer outcomes. The goal of this study was to assess the association of AP at RP, defined as high-grade (> Grade Group 3) and/or non-organ confined disease (pT3), with distant metastasis and prostate cancer death. Methods: A stratified cohort sample of 428 patients was used to evaluate the association of adverse pathology with the risk of distant metastases and prostate cancer-specific mortality over 20 years after prostatectomy in 2641 patients treated between 1987-2004. Cox regression of cause-specific hazards was used to estimate the absolute risk of both endpoints, with death from other causes treated as a competing risk. Subgroup analysis in patients with low/intermediate risk disease potentially eligible for active surveillance was performed. Results: Among the 428 patients, 343 had AUA Low or Intermediate risk disease and 85 had High risk disease. Median follow-up time was 15.5 years (IQR 14.6–16.6 years). Using the cohort sampling weights for estimation, at RP 29.8% of patients had high-grade disease, 42.3 % had non-organ confined disease, 19.3% had both, and thus 52.8% had AP. Adverse pathology was highly associated with metastasis and prostate cancer mortality in the overall cohort (HR 12.30, 95% CI 5.30-28.55, and 10.03, 95% CI 3.42-29.47, respectively, both p<0.001), and in the low/intermediate risk subgroup potentially eligible for active surveillance (HR 10.48, 95% CI 4.18-26.28, and 8.60, 95% CI 2.40-30.84, respectively, both p≤0.001). Conclusions: Adverse pathology at radical prostatectomy is highly associated with future development of metastasis and prostate cancer mortality and may be used as a short-term predictor of outcomes. [Table: see text]

Focal Cryotherapy for Clinically Unilateral, Low-Intermediate Risk Prostate Cancer in 73 Men with a Median Follow-Up of 3.7 Years

2012 ◽  
Vol 62 (1) ◽  
pp. 55-63 ◽  
Author(s):  
Duke Bahn ◽  
Andre Luis de Castro Abreu ◽  
Inderbir S. Gill ◽  
Andrew J. Hung ◽  
Paul Silverman ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Intermediate Risk ◽  
Risk Prostate Cancer

Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: Long-term follow-up of a phase I/II study.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 134-134 ◽  
Author(s):  
C. S. Higano ◽  
T. M. Beer ◽  
M. Taplin ◽  
E. Efstathiou ◽  
A. Anand ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Median Time ◽  
Radiographic Progression ◽  
Long Term Follow Up ◽  
Psa Progression ◽  
Previously Treated ◽  
Pre Treatment ◽  
Anti Tumor Activity

134 Background: MDV3100 is a novel androgen receptor (AR) antagonist selected for potent AR activity and devoid of partial agonist effects. A preliminary report of the phase I/II study described anti-tumor activity and adverse events (Scher HI et al. Lancet. 2010;375:1437). This abstract provides long-term follow-up on time to PSA and radiographic progression in this trial. Methods: Patients (pts) with progressive castration resistant prostate cancer (CRPC) were enrolled in sequential cohorts of 3-6 pts at MDV3100 doses of 30, 60, 150, 240, 360, 480 and 600 mg/day. Once the tolerability of a dose was established, enrollment was expanded at doses ≥60 mg/day to include approximately 12 chemotherapy naïve (naïve) pts and 12 pts previously treated with docetaxel (post-chemo) per cohort. Results: 140 pts were enrolled of which 18 (13%) pts continue on active treatment (16 naive and 2 post-chemo). The median time on treatment is 51 weeks for naïve and 17 weeks for post-chemo groups. Median time on treatment for the 18 patients still on study is 131 weeks. The median time to PSA progression, defined per-protocol as a ≥25% increase in PSA from baseline, was not met for naïve and was 33 weeks for post-chemo groups. Median time to PSA progression by Prostate Cancer Clinical Trials Working Group 2 criteria was 41 weeks for naïve and 20 weeks for post-chemo groups. Median time to radiographic progression was 56 weeks for naive and 24 weeks for post-chemo groups. Circulating tumor cell counts available for 128 of 140 pts showed 91% (70/77) with favorable pre-treatment counts (<5 cells/7.5 mL blood) remaining favorable post-treatment, while 49% (25/51) converted from unfavorable pre-treatment to favorable post-treatment. Conclusions: MDV3100 demonstrates durable anti-tumor activity in pts with CRPC both before and after chemotherapy. Based on these promising results MDV3100 is currently being evaluated in two global phase III studies in pts with metastatic CRPC, the AFFIRM study in pts previously treated with docetaxel and the PREVAIL study in chemotherapy-naïve pts who have progressed on androgen deprivation therapy. [Table: see text]

Gleason upgrading with time in a large, active surveillance cohort with long-term follow-up.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Suneil Jain ◽  
Danny Vesprini ◽  
Alexandre Mamedov ◽  
D. Andrew Loblaw ◽  
Laurence Klotz
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Linear Regression Analysis ◽  
Low Risk ◽  
Disease Rate ◽  
Intermediate Risk ◽  
Rate Of Increase ◽  
Long Term Follow Up

1 Background: Active surveillance (AS) is an accepted management strategy for localized prostate cancer. However, the rate of pathological upgrading has not been well described in mature study cohorts. Furthermore, concern exists over the possibility of prostate cancer dedifferentiation with time in patients on AS. Methods: Patients in our prospectively collected AS database with at least one repeat prostate biopsy were included. Linear regression analysis was used to estimate the proportion of patients upgraded (Gleason 6 to 3+4 or higher, Gleason 3+4 to 4+3 or higher) with time from diagnostic biopsy. Results: 593 of 862 patients in our cohort had at least one repeat biopsy. Median follow-up was 6.4 years (max. 20.2 years). The total number of biopsies ranged from 2 to 6. 20% of patients were intermediate risk, 0.3 % high risk, all others low risk. 31.2% of patients were upgraded during active surveillance. The proportion of patients upgraded increased with time, suggesting prostate cancer dedifferentiation occurred at a rate of 1.0%/year (95%CI -0.12 to 2.16%/year). The estimated rate of increase was 2.5 times higher in patients with intermediate risk disease at diagnosis (rate 1.9%/year, 95%CI -0.7-4.6) compared with those with low risk disease (rate 0.75%/year, 95%CI -0.5-2.0). Further analysis is underway. 62% of upgraded patients (n=114) went on to have active treatment. Patients who were upgraded and treated had significantly greater PSA velocities (median 1.2 ng/ml/y vs 0.42 ng/ml/y, p=0.01) and significantly higher Gleason scores when upgraded, than those who remained on surveillance (21.8% vs 2.8% Gleason 8-10, p<0.01). Conclusions: This is the largest re-biopsy cohort, with long-term follow-up, described to date, enabling the first estimates of prostate cancer dedifferentiation in patients on AS. Dedifferentiation rates appear higher in patients with intermediate risk prostate cancer compared with those who are low risk at baseline.

Urinary obstruction following stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 196-196
Author(s):  
W. Tristram Arscott ◽  
Leonard Chen ◽  
Nathan Wilson ◽  
Aditi Bhagat ◽  
Joy S. Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Urinary Retention ◽  
Symptom Score ◽  
Stereotactic Body Radiation Therapy ◽  
Post Treatment ◽  
Urinary Symptoms ◽  
Obstructive Symptom ◽  
Urinary Function

196 Background: Obstructive urinary symptoms are common following prostate cancer treatment with radiation therapy. Given the higher dose of radiation per fraction using stereotactic body radiation therapy (SBRT) there is concern that post-SBRT obstructive urinary symptoms would be more severe. This study sought to evaluate obstructive urinary symptoms and urinary retention requiring catheterization following SBRT for prostate cancer. Methods: Patients treated with SBRT monotherapy for localized prostate cancer from August 2007 to July 2011 at Georgetown University Hospital with a minimum of two years of follow-up were included in this study. Treatment was delivered using the CyberKnife with doses of 35 Gy to 36.25 Gy in five fractions. Urinary retention was recorded and scored using the CTCAE v.4. Patient-reported urinary symptoms were assessed using the International Prostate Symptom Score (IPSS) before treatment and at months 1, 3, 6, 9, and 12 and every six months thereafter. Results: Two hundred sixty nine patients at a median age of 69 received SBRT with a median follow-up of three years. Prior to treatment, 32.1% of patients utilized alpha-antagonists and 17.8% were dissatisfied with their urinary function. The two-year actuarial incidence rates of acute and late urinary retention greater than or equal to grade 2 were 39.5% and 41.4%. Alpha-antagonist utilization rose at one month (57.9%) and 18 months (48.0%) post-treatment. However, grade 3 urinary retention was low with four men (1.5%) requiring catheterization and/or transurethral resection of the prostate. A mean baseline IPSS obstructive symptom score of 3.6 significantly increased to 5.0 at one month (p < 0.0001), however returned to baseline at three months (p = 0.74). Late IPSS increases were common, but transient. The IPSS obstructive symptom score returned to baseline in 79.6% of patients by six months and 92.6% by two years. Dissatisfaction with urinary function declined to 14% by two years post treatment (p < 0.05). Conclusions: Treatment of prostate cancer with SBRT resulted in an acute increase in obstructive urinary symptoms, which peaked at one month post-treatment. However, the risk of acute urinary retention requiring catheterization was low. Obstructive urinary symptoms returned to baseline in the majority of patients by six months and in more than 90% by two years.

Prostate brachytherapy implant quality on biochemical control.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 128-128
Author(s):  
Don Muller ◽  
Paul Monsour
Keyword(s):  
Prostate Cancer ◽  
Clinical Stage ◽  
Biochemical Failure ◽  
Low Risk ◽  
Prostate Brachytherapy ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Biochemical Control ◽  
Dosimetric Analysis

128 Background: prostate brachytherapy at our institution was analyzed for implant quality on biochemical control. Methods: We treated 368 patients with clinically localized prostate cancer. All patients underwent 1 month CT based dosimetric analysis. Follow up data was available on 289 patients with a minimum follow up of 5 years. Gleason score was 6 in 80% (n=233), and 7 in 20% (n=56). Clinical stage was T1c in 90% of cases (n=260), T2a was 8% (n=23), T2b was <1% (n=3), T2c was < 1% (n=2). The initial prostate-specific antigen was < 10 ng/ml in 95% (n=274), 10.1-20 ng/ml in 5% (15).Patients with low risk disease ( clinical stage T1c, Gleason score 6 with a PSA < 10 ng/ml) n=228. Patients with intermediate risk disease Gleason 7 adenocarcinoma or with a PSA> 10 ng/ml < 20 ng/ml )n= 61. All patients were treated with I (125). All patients underwent a 1-month CT-based dosimetric analysis. The implant dose was defined as the dose delivered to 90% of the prostate volume on post implant dosimetry (D(90)). Results: At minimum follow up of 5 years overall freedom from biochemical failure was 91.4%. For Gleason grade 6 freedom from biochemical failure was 95%. For Gleason grade 7 freedom from biochemical failure was 77%. Based on PSA freedom from biochemical failure for PSA <10 ng/ml at diagnosis was 92 % and for PSA >10 ng/ml and <20 ng/ml was 80%. In patients with low risk disease ( clinical stage T1c, Gleason 6 adenocarcinoma with a PSA < 10ng/ml) the freedom from biochemical failure was 94%. In patients with intermediate risk disease (Gleason 7 adenocarcinoma or with a PSA >10 ng/ml <20 ng/ml ) freedom from biochemical failure was 84%. Patients with optimal dose implants n=264 freedom from biochemical failure was 95%. Patients with suboptimal dose implants n=25 freedom from biochemical failure was 52% Conclusions: With a minimum follow up of 5 years our data support the use of implant alone in low risk prostate cancer patients with a freedom from biochemical failure of 94%. Our data also shows the importance of implant quality in achieving optimal out comes.

Performance of MRI-TRUS-guided fusion biopsy to detect progression on active surveillance for low- and intermediate-risk prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 43-43
Author(s):  
Thomas P. Frye ◽  
Nabeel Ahmad Shakir ◽  
Steven Abboud ◽  
Arvin Koruthu George ◽  
Maria J Merino ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Low Risk ◽  
Intermediate Risk ◽  
Targeted Biopsy ◽  
Fusion Biopsy ◽  
Trus Biopsy ◽  
Guided Biopsy ◽  
Risk Prostate Cancer

43 Background: Active surveillance (AS) is an established treatment option for men with low risk prostate cancer. Its role in intermediate prostate cancer is still being investigated. Recent studies have shown that multiparametric-MRI (mp-MRI) along with MRI-TRUS fusion-guided biopsy may better assess risk in patients eligible for AS, compared to 12-core biopsy, due to improved detection of clinically significant cancers. The objective is to determine the performance of MRI-TRUS guided biopsy for men on AS with both low and intermediate risk disease. Methods: Between 2007-2014 men on AS were included if they had complete mp-MRI and pathology data for 2 or more MRI-TRUS biopsy sessions. Fusion guided biopsy procedures consisted of MRI identified targeted biopsies as well as random 12 core biopsies. Men were allowed to participate in AS with low and intermediate risk prostate cancer, Gleason score ≤ 3+4=7. Progression was defined by patients with initial Gleason 3+3=6 to any Gleason 4, and Gleason 3+4=7 disease progressing to a primary Gleason 4 or higher. Results: 89 men met our study criteria with an average age of 62 years old (range 45-79). 75 men had low risk Gleason 3+3=6 at the outset of AS by 1st biopsy session with a median PSA 5.1 ng/ml. The other 14 men had intermediate risk prostate cancer Gleason 3+4=7 at the outset of AS and a median PSA 4.6 ng/ml. During follow-up, 25 (33%) low risk men progressed to 3+4 or above at a median of 20.6 months. Of these, 19 were found by targeted biopsy. 6 (43%) of the intermediate risk men progressed to Gleason 4+3=7 at a median of 36.8 months. 4 of these progressed on targeted fusion biopsy. In the intermediate risk men, 84 random biopsy cores were require to detect 1 progression versus 15 targeted biopsy cores to detect 1 progression. Conclusions: The majority of patients on AS who progressed were identified by MRI-TRUS targeted biopsy. Less biopsy cores are required to detect progression with targeted biopsy. These results are preliminary and a larger cohort with longer follow-up would be beneficial.

Prognostic value of copy-number alterations of the Cohesin complex in intermediate-risk prostate cancer recurrence.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 49-49
Author(s):  
Jonathan So ◽  
Melvin Chua ◽  
Emilie Lalonde ◽  
Osman Mahamud ◽  
Alejandro Berlin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Copy Number ◽  
Intermediate Risk ◽  
Cohesin Complex ◽  
Biochemical Relapse ◽  
Copy Number Alterations ◽  
Image Guided Radiotherapy ◽  
Image Guided ◽  
Risk Prostate Cancer ◽  
Pre Treatment

49 Background: The Cohesin complex plays a critical role in mitotic progression and post-replicative DNA damage repair. It serves to bring together sister chromatids both in metaphase and in homologous recombination repair following ionizing radiation. The complex has also been shown to be phosphorylated in the ATM/BRCA1 pathway. The expression of various proteins in the complex are dysregulated in many cancers: breast, prostate, etc. Interestingly, in breast cancer cell lines, Cohesin is required for MYC activation in response to estrogen. Our study sought to correlate copy number alterations in this pivotal complex with biochemical relapse in prostate cancer patients. Methods: Our cohort consists of 284 patients with D’ Amico-classified intermediate-risk prostate cancer, treated with image-guided radiotherapy (IGRT, N = 143) or radical prostatectomy (RadP, N = 141). Pre-treatment biopsies and prostatectomy samples were analyzed using the Affymetrix Oncoscan array. The Phoenix and AUA criteria was used to define biochemical relapse for RadP and IGRT patients respectively. Results: Copy number alterations of RAD21, SMC1B, and STAG1 were observed in 18% (n = 52), 6.3% (n = 18), and 12% (n = 35) of the cohort respectively. They were predominantly losses in SMC1B, but gains in RAD21 and STAG1. All three genes in the Cohesin complex were associated with increased risk of biochemical relapse: RAD21 on chromosome 8 (HR = 1.93, 95% CI 1.23, 3.02, Wald’s p = 0.004), SMC1B on chromosome 22 (HR = 3.37, 95% CI 1.91, 5.94, Wald’s p < 10-4), and STAG1 on chromosome 3 (HR = 1.74, 95% CI 1.04, 2.89, Wald’s p < 0.05). However, when controlled for percent genome alteration and pre-treatment serum PSA levels, only copy number loss of SMC1B was a significant predictor of biochemical relapse (HR = 2.95, 95% CI 1.62, 5.38, Wald’s p < 10-3). Conclusions: We identified a novel association of copy-number alterations in members of the Cohesin complex with biochemical recurrence following radical prostatectomy or image-guided radiotherapy. This points to the central role of Cohesin in cell-cycle and DNA damage pathways promoting prostate cancer progression.

Early toxicity in a prospective phase I/II trial of MRI-assisted focal boost integrated with HDR monotherapy for low- and intermediate-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 120-120
Author(s):  
Laura D'alimonte ◽  
Joelle Antoine Helou ◽  
Gerard Morton ◽  
Hans T. Chung ◽  
Merrylee McGuffin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
High Dose Rate ◽  
High Dose ◽  
Intermediate Risk ◽  
Hdr Brachytherapy ◽  
Gu Toxicity ◽  
Risk Prostate Cancer ◽  
Prospective Phase

120 Background: There is growing evidence for the use of High Dose Rate (HDR) brachytherapy as monotherapy for the treatment of low and intermediate risk prostate cancer patients. With the increasing availability of magnetic resonance imaging (MRI) there is an opportunity to further escalate dose to the dominant intraprostatic lesion (DIL). We report acute toxicity of this prospective phase I/II trial. Methods: Eligible patients had low- and intermediate risk prostate cancer, IPSS < 16, were medically eligible for HDR brachytherapy treatment and had an identified DIL on multiparametric MRI (mpMRI) prior to brachytherapy treatment. Patients were treated with 19 Gy delivered in one fraction to the whole prostate. A 0-5mm expansion was applied to the DIL to define the PTV DIL, with a DIL PTV D90 to receive > 23Gy based on previous experience. Toxicity was assessed using CTCAE v.4.0 at baseline, 6 weeks 3, 6, 9 and 12 months post brachytherapy. Results: A total of 34 patients have undergone HDR monotherapy treatment with an integrated DIL boost with a median follow up of 6 months. The median age was 67 years (range 46-80). At presentation, median PSA was 6.1 ng/mL (range 2.5-16.4). Three, 26, and 6 patients had low, low intermediate and high intermediate risk disease. Baseline characteristics were PIRAD 5 (n = 21) and PIRAD 4 (n = 13), median prostate volume was 38 cc (range 18-54). The median DIL volume was 2.8 cc (range 1.14-7.8). The median DIL D90 was 27 Gy (range 19-35.8). No patients experienced acute or late grade 2+ GI toxicity. The percentage of acute grade 2 GU toxicity were as follows; retention 62%, frequency 18%, urinary tract pain 6%. One patient had acute clot retention requiring catheterization x1 day and has been catheter-free since. Late grade 2 GU toxicity (alpha blockers) was reported in 6/16 patients at 6 months. Conclusions: The use of mpMRI to define and further escalate dose to the DIL using HDR monotherapy is feasible with minimal acute toxicities. Further long term follow up is required to determine the efficacy of treatment, and impact on quality of life and late toxicities. Clinical trial information: NCT02623933.

Single-dose radiotherapy (SDRT) in the management of intermediate risk prostate cancer: Early results from a phase II randomized trial.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 128-128 ◽  
Author(s):  
Carlo Greco ◽  
Nuno Pimentel ◽  
Oriol Pares ◽  
Vasco Louro ◽  
Zvi Y. Fuks
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Foley Catheter ◽  
Prostate Gland ◽  
Intermediate Risk ◽  
Time Motion ◽  
Early Results ◽  
Randomized Phase Ii ◽  
Patient Reported

128 Background: To report initial response, acute treatment-related toxicity and patient-reported quality of life (QoL) after 24Gy SDRT derived from a randomized Phase II study of patients with intermediate-risk adenocarcinoma of the prostate (NCCN definition). Methods: Between November 2015 and December 2016, 30 hormone-naïve patients were enrolled in an IRB-approved prospectively randomized phase II study to receive either 45Gy in 5 consecutive daily fractions (Hypo-SBRT) or 24Gy SDRT. Treatment was based on VMAT-IGRT with urethral sparing via a dose-painting technique and real-time motion management with beacon transponders. The PTV included the MR-delineated prostate gland and seminal vesicles with 2 mm margin. Precise PTV targeting and anatomical reproducibility was achieved via placement of an endorectal air-filled balloon (150 cc) and a Foley catheter. This setup also conferred organ motion mitigation, and online tracking ensured treatment delivery within the 2 mm PTV margin.. Genito-urinary (GU) and gastro-intestinal (GI) toxicity were graded according to the NCI CTCAE v.4, and QoL was assessed by EPIC and IPSS questionnaires. Tumor response was assessed biochemically (PSA) and by follow-up MRI at 3 months after treatment and at 6 months intervals thereafter. Results: With a median follow-up of 16 months (range, 11-24), no grade ≥2 acute GI or GU toxicities were observed in either group. There were no significant differences in mean EPIC scores in all domains. An initial 6% and 8% drop in the EPIC urinary domain score occurred in the hypo and SDRT arm respectively, returning to baselines by 3 months. . PSA reduction kinetics were similar between the two regimens, reaching ≤1 ng/mL by 18 months. Of note, all cases, regardless of treatment regimen, converted to non-detectable disease on MRI at 6 months. Patients in this trial will receive a planned 24 months post-treatment biopsy to validate treatment outcome. Conclusions: These early trial outcomes indicate that 24Gy SDRT can be consistently and safely delivered, yielding the same low acute toxicity as demonstrated with the hypo 5x9Gy schedule, and is associated with excellent QoL measures. Clinical trial information: NCT02570919.

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