scholarly journals Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0252040
Author(s):  
Nicolas Barry Delongchamps ◽  
Alexandre Schull ◽  
Julien Anract ◽  
Jean-Paul Abecassis ◽  
Marc Zerbib ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Microwave Ablation ◽  
Intermediate Risk ◽  
Oncological Outcomes ◽  
Patient Reported ◽  
Risk Prostate Cancer ◽  
Show Evidence ◽  
Index Tumor ◽  
Baseline Psa

Objective To assess the feasibility, safety and precision of organ-based tracking (OBT)-fusion targeted focal microwave ablation (FMA), in patients with low to intermediate risk prostate cancer. Patients and method Ten patients with a visible index tumor of Gleason score ≤3+4, largest diameter <20mm were included. Transrectal OBT-fusion targeted FMA was performed using an 18G needle. Primary endpoint was the evidence of complete overlap of the index tumor by ablation zone necrosis on MRI 7 days after ablation. Urinary and sexual function were assessed with IPSS, IIEF5 and MSHQ-EjD-SF. Oncological outcomes were assessed with PSA at 2 and 6 months, and re-biopsy at 6 months. Results Median [IQR] age was 64.5 [61–72] years and baseline PSA was 5 [4.3–8.1] ng/mL. Seven (70%) and 3 (30%) patients had a low and intermediate risk cancer, respectively. Median largest tumor axis was of 11 [9.0–15.0] mm. Median duration of procedure was of 82 [44–170] min. No patient reported any pain or rectal bleeding, and all 10 patients were discharged the next day. Seven days after ablation, total necrosis of the index tumor on MRI was obtained in eight (80% [95%CI 55%-100%]) patients. One patient was treated with radical prostatectomy. Re-biopsy at 6 months in the other 9 did not show evidence of cancer in 4 patients. IPSS, IIEF-5 and MSHQ-EjD-SF were not statistically different between baseline and 6 months follow up. Conclusions OBT-fusion targeted FMA was feasible, precise, and safe in patients with low to intermediate risk localized prostate cancer.

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

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.

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.

The relative contributions of the Genomic Prostate Score and comorbidity profile in predicting outcomes in surgically treated men with clinically low and intermediate-risk prostate cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16607-e16607
Author(s):  
Jennifer Cullen ◽  
Dudith Pierre-Victor ◽  
H. Jeffrey Lawrence ◽  
Huai-Ching Kuo ◽  
Isabell Sesterhenn ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Intermediate Risk ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Risk Stratum ◽  
Diagnostic Biopsy ◽  
Using Data

e16607 Background: The 17-gene Oncotype Dx Genomic Prostate Score® (GPS™) assay has been validated as a predictor of aggressive prostate cancer (PCa) in men treated with radical prostatectomy (RP) for clinically low and intermediate risk PCa. This study examined the performance of the GPS assay as a predictor of adverse pathology (AP) and biochemical recurrence (BCR)-free survival (BRFS), after adjusting for the presence of major comorbidities commonly seen in older men. Methods: Additional analyses were performed using data from a prior clinical validation study of the GPS assay. GPS values (scaled 0-100), determined from diagnostic biopsy tissue, were categorized into 3 levels: lowest quartile (Q1), middle quartiles (combined Q2-Q3) versus the highest quartile (Q4). Major comorbidities included heart disease, stroke, COPD, and other cancers. The associations between GPS result and the presence of ≥1 major comorbidity and outcomes were examined. AP was defined as high-grade (Gleason Score ≥ 4+3) and/or pT3 tumor. BCR was defined as 2 successive PSA levels > 0.2 ng/mL. Logistic regression analysis was used to examine AP; Cox proportional hazards analysis was used to model BRFS. Results: Among 389 eligible men, median age at diagnosis and follow-up time was 62 and 5.6 years, respectively. The prevalence of ≥1 major comorbidity differed significantly across GPS category, rising from 10.2% to 19.7% to 25.5% for GPS Quartiles 1, 2-3, and 4, respectively (p = 0.0024). However, presence of ≥1 major comorbidity was not a significant predictor of AP or BCR in multivariable models with GPS, age, race, and NCCN risk stratum. Men whose GPS result was in the highest quartile had 4-fold higher odds of AP (OR: 4.1; 95% CI = 2.1-7.99, p < 0.0001) at RP and a 3.5 times higher risk of BCR (HR = 3.49; 95% CI = 1.59-7.64, p = 0.002) compared to men in the lowest GPS quartile (Table 1). Conclusions: A high GPS result remains the strongest predictor of BCR and AP in this cohort of low and intermediate risk PCa men, after adjusting for the presence of major comorbidities. Further work will explore the relationships between specific comorbidities and metabolic syndrome, with GPS testing and PCa outcomes.

scholarly journals PD30-07 PATIENT REPORTED FUNCTIONAL OUTCOMES AFTER 5 YEARS IN MEN WITH LOW- AND FAVORABLE INTERMEDIATE-RISK PROSTATE CANCER

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Daniel D. Joyce* ◽  
Aaron A. Laviana ◽  
Zighuo Zhao ◽  
Karen E. Hoffman ◽  
Li-Ching Huang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Functional Outcomes ◽  
Intermediate Risk ◽  
Patient Reported ◽  
Risk Prostate Cancer

Using NBN to predict biochemical relapse following image-guided radiotherapy (IGRT) for intermediate-risk prostate cancer (IR-PCa).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 26-26
Author(s):  
Alejandro Berlin ◽  
Emilie Lalonde ◽  
Gaetano Zafarana ◽  
Jenna Sykes ◽  
Varune Rohan Ramnarine ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Copy Number ◽  
Prostate Cancer Cell ◽  
Local Treatment ◽  
Intermediate Risk ◽  
Biochemical Relapse ◽  
Image Guided Radiotherapy ◽  
Image Guided ◽  
Risk Prostate Cancer

26 Background: Despite the use of clinical prognostic factors, 20 to 40% of patients with intermediate-risk prostate cancer (IR-PCa) fail local treatment for unexplained reasons. Given that an accurate DNA damage response (DDR) may be associated with genetic instability and radioresponse, we investigated whether copy number alterations (CNAs) in DDR genes are predictive or prognostic following local treatment. Methods: Using array comparative genomic hybridization (aCGH), we characterized CNAs in biopsies derived from 126 IR-PCa pts. who underwent image-guided radiotherapy (IGRT). We studied the DDR-sensing genes: MRE11A, RAD50, NBN, ATM, and ATR. The IGRT cohort (median dose: 76.4Gy; median follow-up: 7.8yrs) was compared to a radical prostatectomy (RP) cohort (154 pts. from Memorial Sloan-Kettering Cancer Center database; median follow-up: 4.8yrs). CNAs were then tested for their independent prognostic capability using Kaplan-Meir method and Cox proportional hazard models. Results: In our IGRT cohort, m,ost frequent DDR gene CNAs were: NBN 20 of 126 (15.9%), ATR 11of 126 (8.7%), and ATM 7 of 126 (5.5%). NBN CNAs were mainly gains (19/20) and strongly correlated with increased NBN-mRNA abundance compared to NBN-neutral cases (p=0.016). CNAs in DDR genes were not associated with GS, prostate-specific antigen, or T-stage. Importantly, NBN gain ranked among the top 3.3% of all genes in terms of its strength of association with the percent of the genome altered (PGA). After adjusting for clinical factors in a multivariate model, NBN gain was a significant independent predictor of 5 years-biochemical relapse-free rate (bRFR) following IGRT (48.6% versus 78.8%; HR = 3.14, 95% CI: 1.42-6.94, p=0.004). No DDR CNA was prognostic in the RP cohort. Increased NBN mRNA expression correlated to radioresistance in vitro (i.e. clonogenic surviving fraction after 3Gy) in five prostate cancer cell lines (R2= 0.665). This relationship was not observed for any of the other DDR genes. Conclusions: NBN copy number gain or increased expression correlates with tumor genomic instability, decreased bRFR (IGRT- but not surgery-treated pts.) and intrinsic prostate cancer cell radioresistance. If validated in independent IGRT cohorts, NBN gain could be the first PCa predictive biomarker to facilitate local treatment decisions using precision medicine approaches.

Short-course hormonal therapy and the risk of death from prostate cancer in men with intermediate-risk prostate cancer undergoing high-dose radiation therapy.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 27-27
Author(s):  
Florence K. Keane ◽  
Ming-Hui Chen ◽  
Danjie Zhang ◽  
Brian Joseph Moran ◽  
Michelle H. Braccioforte ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Dose ◽  
Intermediate Risk ◽  
Risk Of Death ◽  
Short Course ◽  
Significant Difference ◽  
Risk Prostate Cancer ◽  
Cancer Specific Mortality ◽  
The Impact

27 Background: We assessed the risk of prostate cancer-specific mortality (PCSM) in men with unfavorable and favorable intermediate-risk prostate cancer (PC) who received dose-escalated radiotherapy (RT) with or without short-course androgen deprivation therapy (ADT). Methods: The cohort consisted of 2,668 men with intermediate-risk PC (71.3% favorable, 28.7% unfavorable) who were treated with dose-escalated RT with or without ADT (median 4 mos.) from 1997 - 2013. Fine and Gray's competing risks regression was used to assess whether ADT decreased PCSM-risk in an adjusted multivariable model (Table). An interaction term was included to assess for potential differences in the impact of ADT on PCSM risk in men with favorable versus unfavorable intermediate-risk PC. Results: After a median follow-up of 7.84 years, there were 393 deaths (14.73%), of which 33 were from PC (8.40%). There was significant reduction in PCSM-risk in men with unfavorable intermediate-risk PC who received ADT (AHR 0.39, 95% CI 0.16 to 0.92, P=0.033), but no significant difference in PCSM-risk in men with favorable intermediate-risk PC who received ADT (AHR 0.68, 95% CI 0.19 to 2.49, P=0.561). Conclusions: While ADT reduced PCSM-risk in men with unfavorable intermediate-risk PC, there was no significant improvement in men with favorable intermediate-risk PC, suggesting that for these patients ADT in addition to dose-escalated RT may not be required to minimize PCSM-risk. [Table: see text]

Prostate specific antigen five years following stereotactic body radiation therapy (SBRT) for low and intermediate risk prostate cancer: An ablative procedure?

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 123-123
Author(s):  
Shaan Kataria ◽  
Harsha Koneru ◽  
Shan Guleria ◽  
Malika Danner ◽  
Marilyn Ayoob ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
University Hospital ◽  
High Rate ◽  
Total Testosterone ◽  
Intermediate Risk ◽  
Biochemical Relapse ◽  
Risk Prostate Cancer ◽  
Psa Nadir

123 Background: Our previous work on early PSA kinetics following prostate SBRT showed that an initial rapid and then slow PSA decline may result in very low PSA nadirs. This retrospective study sought to evaluate the PSA nadir 5 years following SBRT for low and intermediate risk prostate cancer (PCa). Methods: 65 low and 80 intermediate risk PCa patients were treated definitively with SBRT at Georgetown University Hospital between January 2008 and October 2011. All patients were treated to 35-37.5 Gy in 5 fractions delivered via the CyberKnife Radiosurgical System. Patients who received androgen deprivation therapy were excluded from this study. Pre- and post-treatment PSA and total testosterone levels were obtained during routine follow up visits. Biochemical relapse was defined as a PSA rise > 2 ng/mL above the nadir and analyzed using the Kaplan Meier method. The PSA nadir was defined as the lowest PSA value prior to biochemical relapse or as the lowest value recorded during follow up. Prostate ablation was defined as a PSA nadir < 0.2 ng/mL. Univariate logistic regression analysis was used to evaluate relevant variables on the likelihood of achieving a PSA nadir < 0.2 ng/mL. Results: The median age at the start of SBRT was 72 years. These patients had a median prostate volume of 36 cc with a median 25% of total cores involved. At a median follow up of 5.8 years, 84% and 37% of patients achieved a PSA nadir ≤ 0.5 ng/mL and < 0.2 ng/mL, respectively. Five low and 8 intermediate risk patients experienced a biochemical relapse; those who did not experience a biochemical relapse, achieved a median PSA nadir of 0.2 ng/mL. There was no difference between the 5-year bRFS rate for low (96.6%) and intermediate risk (97.4%) patients and the median time to PSA nadir was 36 months. Initial PSA (p = 0.024) and a lower testosterone at the time of the PSA nadir (p = 0.049) were found to be significant predictors of achieving a PSA nadir < 0.2 ng/mL. Conclusions: SBRT for low and intermediate risk PCa is a convenient treatment option with low PSA nadirs and a high rate of early bRFS. Less than 40% of patients achieved an ablative PSA nadir. Thus, the role of further dose escalation is an area of active investigation.

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