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178 Abstracts

  • Introduction & Objectives

    To evaluate a possible role for prophylactic irradiation of the pelvic lymph-nodal area (WPRT) in the postoperative setting for prostate cancer (PCa) in increasing the risk of potentially radiation-induced second malignancies (SM).

    Material & Methods

    From 1993 to 2011, 1109 patients (pts) (median age=65 years) were treated with postoperative ADV (n=739) or SALV (n=370) non conformal RT (n=169), 3DCRT (n=670) or static-fields IMRT (SS-IMRT, n=57) at 1.80 Gy/fr (median dose=70.2Gy), with moderately hypofractionated regimens (median dose=2.35Gy/fr) with Tomotherapy (n=213) at a median 2Gy equivalent (EQD2, α/β=3) dose of 70Gy. WPRT was delivered to 336 pts at a median EQD2 dose of 50 Gy. 510 pts received adjuvant hormonal therapy for a median of 21 months. The median follow-up (FU) was 124 months.

    Results

    139 pts developed SM, including 73 in-field (IN) and 66 out-field (OUT), after a median of 65, 80 and 56 months, respectively. At univariate analysis, there was no statistical difference of 10-year risk SM/IN/OUT for pts receiving prostatic bed (PB) only or PB+WPRT (Figure 1a). No role emerged for RT dose, technique or fractionation. A borderline predictive role of the 10-year risk of SM was found in patients experiencing any (acute/late) GU+GE Grade≥2 (p=0.12), while GE and GU G≥2 showed a correlation with the risk of IN (p=0.21) and OUT (p=0.12), respectively. Age showed a statistically significant correlation with the risk of SM (p≤0.05). Of note, only for patients treated with WPRT, a slight correlation between IMRT techniques and increased risk of OUT (p= 0.26, HR= 1.78) emerged (Figure 1b). Multivariable analysis, including all variables with p65 years in all subgroups.

    Conclusions

    Though preliminary, this study does not indicate any additive risk of SM arising from the use of prophylactic WPRT in the postoperative setting for PCa. Overall, the risk of SM development appeared fundamentally as a function of aging. Nevertheless, in the sole pts treated with WPRT a slight correlation, absolutely to be confirmed, between IMRT techniques and risk of OUT emerged. An analysis focused on tumours arose at least 5 years after RT has been precluded owing  the low number of events (n=47, 4%).

  • Introduction & Objectives

    The high incidence of prostate cancer (PCa) in worldwide and the growing interest in overdiagnosis and overtreatment have made the study of new markers imperative for helping us predict the presence and aggressiveness of the tumor.

    Material & Methods

    A prospective study including 101 patients with PSA levels between 3 and 10 ng/mL and normal digital rectal exam was conducted between November 2013 and November 2014. All patients underwent prostate biopsy and level determination of PSA, free PSA and -2proPSA. The -2pro PSA ratio (%2proPSA) and Prostate Health Index (PHI) were also calculated from this data.

    Results

    A total of 101 patients were included in a one-year period evaluation time. Patients had a mean age of 63.7 years old. The means of PSA and free PSA ratio (%fPSA) were 6.06 ng/mL and 16%, respectively. The means of -2proPSA and %2proPSA were 16.8% and 1.8%, respectively. The prostate volume mean was 46 cc and the PSA density mean was 0.19 ng/cc.
    In the univariate analysis, only %fPSA and PHI showed statistical significant association with the presence of tumor in prostate biopsy, whereas %2proPSA almost reached statistical significance.
    In the multivariate analysis, PHI showed the best area under the curve (AUC) with a value of 0.749, followed by %fPSA (0.708) and -2proPSA (0.671).
    The best values for internal and external validity of each of the evaluated parameters turned out to be for PHI, with 93% sensibility and 37% specificity, 53% positive predictive value (PPV) and 88% negative predictive value (NPV).

    Conclusions

    PHI is the parameter that allows predicting the presence of PCa more precisely for patients with normal digital rectal exam and PSA between 3 and 10 ng/mL.

  • Introduction & Objectives

    In patients with a prostate specific antigen (psa) failure after radical treatment for prostate cancer ,PET/CT with [11C]choline may accurately detect the presence of recurrence.
    Prostate pathology studies suggest in many cases a dominant cancer focus exists within the gland and may be a driver of the aggressiveness of the cancer and the epicenter of recurrence following radiotherapy treatment.
    We investigated the role of integrated [11C]choline PET/CT for target volume selection and delineation  in patients with recurrent prostate cancer following EBRT for a salvage focal Cyberknife Stereotactic Hypofractionated Radiotherapy (SBRT) treatment.

    Material & Methods

    From December 2012 through October 2014 a cohort of 16 patients with a median age of 76 years (range 64 -84) and an history of second locally-recurrent prostate cancer following first salvage Cyberknife SBRT in biochemical relapse after external beam radiotherapy treatment were referred to our department for a focal salvage Cyberknife SBRT.
    Primary EBRT radiotherapy doses ranged from 74 to 79.2 Gy (median 76 Gy) while Cyberknife Sbrt salvage treatment doses ranged from 30-35 Gy in 5 fractions.  The median pre- focal Ck reirradiation PSA was 4,46 ng/ml (range,1,23 -13,04 ng/ml). To reconstruct CTV and organ at risk, CT scan and MRI with T1-T2 sequences were performed and [11C]choline PET/CT images were fuse for focal prostate  target volume definition and delineation.
    In 4 patients focal Cyberknife sbrt treatment consisted of 3 fractions of 10 Gy (total Dose 30 Gy), in the other 12 patients 3 fractions of 12 Gy for a total dose of 36 Gy were delivered. The [11C]choline PET/CT median prostate node volume was of 14,3 cc (range 5,75-65,04).

    Results

    The focal salvage Cyberknife treatment was well tolerated without any rtog grade 3 acute or late toxicity. With a median follow up of 11 months (range 3-22) we observed the following results: No in field recurrence, resulting in a local control of 100%. In 3 patients, respectively at 11, 13 at 21 months after Ck focal treatment we observed a biochemical relapse, a [11C]choline PET/CT detect the presence of a new  local recurrence outside the irradiated field requiring a third Cyberknife focal salvage treatment.

    Conclusions

    In clinical practice, advances in modern imaging show promise for improved detection and characterization of prostate cancer at the different stage of its management including diagnosis, staging treatment planning and follow up. According to available literature [11C]choline PET/CT is not clinically recommendable to plan target volume, nevertheless, our promising data suggest a potential role of [11C]choline PET/CT as an image guide tool for the irradiation of focal prostate cancer relapse. Prospective trials are needed to better define the role of differential prostate treatment on imaging defined GTVs.

  • Introduction & Objectives

    [11C]choline PET/CT has been established as a diagnostic tool in re-staging patients with biochemical failure after radical treatment for prostate cancer in particular for its capability to detect the presence of lymph node and bone metastases.
    The knowledge of the anatomical site of recurrence may be useful to refer patients to the specific tailored therapy, in addition to the conventional anti-hormonal therapy.
    We investigated the role of [11C]choline PET/CT as an image method for target volume definition  and delineation  in patients with oligometastatic prostate cancer  for Cyberknife stereotactic tailored therapy.

    Material & Methods

    Between March 2009 and march 2013 a cohort of 30 patients with up to 3 synchronous lymph node prostate oligometastases staged with [11C]choline PET/CT (47 lesions, median volume 12,92 cc, range 0,39 -111,67), following biochemical recurrence after local curative treatment were treated with Cyberknife Stereotactic Body Radiotherapy (SBRT) in our Center. In all patients [11C]choline PET/CT images was used to select and to delineate target volumes at lymph node recurrent sites. The mean age of patients population at the time of the Cyberknife treatment was 68 years (range 55-84). Cyberknife prescription doses were 3000-3600 cGy delivered in 3 consecutive fractions of 1000-1200 cGy. In 14 lesions (37%) SBRT was performed as re-irradiation (the recurrent lesion was situated in the previously irradiated volume).

    Results

    The Cyberknife treatment was well tolerated without any acute or late toxicity at all. There were no in field recurrence, resulting in a local control of 100%. Eleven and 3 patients, respectively required a second and third salvage treatment for metachronous metastatic disease. The median time to clinical progression was 14 months (range 3-54). After a median follow up of 33 months (range 13-73) 16 patients started with Androgen Deprivation Therapy (ADT) because of polymetastatic disease resulting in an ADT-FS of 80% at 1 year and 65% at 2 years. The median time ADT was deferred resulted of 26 months (range 4-56).

    Conclusions

    The recent evidence of the potential toxic nature of ADT suggest that effective local therapy might reduce the burden of systemic therapies usually given to patients with metastatic prostate cancer. Although there are not literature data that support the use of [11C]choline PET/CT to plan target volume at lymph nodal level our preliminary results are promising, showing that the treatment is well tolerated with excellent rate of local control and suggest a potential role of [11C]choline PET/CT to select and refer patients to specific treatment strategies.

  • Introduction & Objectives

    TAK-385 is an investigational, oral, non-peptide GnRH-selective antagonist of the human GnRH receptor (IC50 0.12 nM). This phase 2, randomized, open label, parallel group study (NCT02135445) was designed to evaluate the testosterone (T)-lowering efficacy as well as safety and PK of TAK-385 (N=60) vs the injectable peptide GnRH antagonist, degarelix (DGX; N=40). We now report results from the prespecified interim analysis conducted after 30 patients had received at least 12 weeks of TAK-385.

    Material & Methods

    Men aged ≥18 years with intermediate risk localized prostate cancer appropriate for EBRT and 6 months ADT, with baseline T >150 ng/dL, and PSA >2 ng/mL were randomized to receive open label oral TAK-385 320 mg as loading dose on day 1 then 120 mg once daily (QD) or DGX 240 mg on day 1 then 80 mg subcutaneously every 4 weeks (Q4W), for 24 weeks. Patients had at least 12 weeks of ADT prior to EBRT. The primary endpoint was the proportion of patients achieving and maintaining castrate T levels <50 ng/dL from the start of week 5 to end of week 24 (5–24 weeks). Secondary endpoints included prostate size reduction, safety, plasma PK, LH levels, and PSA kinetics. PK, T, and/or PSA were assessed on days 1, 2, 4, 8, 15 and 29, and then every 4 weeks, and prostate volume by TRUS/CT/MRI at 8–12 weeks.

    Results

    At data cut-off, 30 patients had received TAK-385 120 mg QD (median age 71 yrs [range 60–80]) and 20 patients received DGX 80 mg Q4W (median age 70.5 yrs [58–81]); overall median treatment duration was 19.5 weeks (0.1–25). At 1 day after first dose, median T levels were 50.0 ng/dL (25.1–306.9) with TAK-385 and 49.0 ng/dL (25.1–223.9) with DGX. At 12 weeks, median T was further reduced to 8.2 ng/dL (2.9–53.0) with TAK-385 and 9.7 ng/dL (4.6–27.1) with DGX. T <50 ng/dL was sustained in 93% (TAK-385) vs 85% (DGX) of patients from 5–24 weeks. After 4 weeks, PSA was reduced by a median 70.5% to 2.4 ng/mL (0.3–11.7) with TAK-385 vs 76.4% to 2.0 ng/mL (0.6–14.9) with DGX. At 12 weeks, PSA was reduced by a median 91.6% to 0.6 ng/mL (0.1–5.5) with TAK-385 vs 90.5% to 0.8 ng/mL (0.1–12.7) with DGX. After 8 weeks, median prostate volume reduction was 30% (TAK-385) vs 29% (DGX). TAK-385 PK profile in patients was similar to that in healthy men (MacLean et al, ENDO 2013, Abstract SAT-318); observed 12-week steady state plasma trough concentrations were on average 2-fold higher than the target of 4 ng/mL for sustained castration. At data cut-off, no patients had discontinued due to adverse events (AEs); the most common AEs were (TAK-385/DGX): hot flush (60%/70%), fatigue (7%/15%), and dysuria (0%/15%).

    Conclusions

    Based on these interim results, oral TAK-385 (120 mg/day) demonstrated similar rapid T-lowering efficacy vs injectable DGX. PSA response and prostate volume reductions were similar across the 2 arms. The safety and tolerability profile of TAK-385 was acceptable and consistent with the anticipated treatment effect.

    Session: Oral presentations of the best abstracts

    Location: Saturday, 14 November 2015, 08:50 - 09:30, Auditorium

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