scholarly journals Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy (Results of the Planned Interim Analysis)

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1133
Author(s):  
Marcus Beck ◽  
Pirus Ghadjar ◽  
Felix Mehrhof ◽  
Daniel Zips ◽  
Frank Paulsen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Radical Prostatectomy ◽  
Interim Analysis ◽  
Regional Hyperthermia ◽  
Salvage Radiation Therapy ◽  
Primary Endpoints ◽  
Randomized Phase Ii ◽  
Grade 3 ◽  
Specific Symptoms

Efforts to improve the outcome of prostate cancer (PC) patients after radical prostatectomy (RP) include adjuvant or salvage radiation therapy (SRT), but still up to 50% of patients develop a disease progression after radiotherapy (RT). Regional hyperthermia (HT) is well-known to improve tumor sensitivity to RT in several entities. Here we report on a planned interim analysis of tolerability and feasibility after recruitment of the first 50 patients of a trial combining SRT and HT. We conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate-NCT04159051) investigating the implementation of combined moderate-dose escalated SRT (70 Gy in 35 fractions) and locoregional deep HT (7–10 HT sessions). The primary endpoints were the rate of acute genitourinary (GU), gastrointestinal (GI), and HT-related toxicities, completed HT sessions (≥7), and SRT applications per protocol (≥95% of patients). The two-step design included a planned interim analysis for acute GU-, GI- and HT-specific toxicities to ensure patients’ safety. Between November 2016 and December 2019, 52 patients entered into the trial. After 50 patients completed therapy and three months of follow-up, we performed the planned interim analysis. 10% of patients developed acute grade 2 GU and 4% grade 2 GI toxicities. No grade ≥3 GU or GI toxicities occurred. HT-specific symptoms grade 2 and 3 were observed in 4% and 2% of all patients. Thus, the pre-specified criteria for safety and continuation of recruitment were met. Moreover, ≥7 HT treatments were applicable, indicating the combination of SRT + HT to be feasible. Evaluation of early QoL showed no significant changes. With its observed low rate of GU and GI toxicities, moderate and manageable rates of HT-specific symptoms, and good feasibility, the combined SRT + HT seems to be a promising treatment approach for biochemical recurrence after RP in PC patients.

Salvage radiation therapy after radical prostatectomy with the use of new technologies in radiation oncology

2016 ◽  
Vol 21 (1-2) ◽  
pp. 26-31
Author(s):  
S. I Tkachev ◽  
V. B Matveev ◽  
Petr V. Bulychkin
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Radical Prostatectomy ◽  
New Technologies ◽  
Treatment Options ◽  
Clinical Recurrence ◽  
Salvage Radiation Therapy ◽  
Prostate Bed ◽  
Grade 3

Introduction: prostate cancer (PCa) is the second cancer after lung one among all males. The main treatmentfor patients with localized prostate cancer is a radical prostatectomy (RP). After RP PCa occurs in patients at the T1-T2 stage - in 25 - 35% of all cases and in patients at the T3 stage - in 33.5 - 66% of all cases. Currently, one of the treatment options for patients with recurrence PCa after RP is a «salvage» radiation therapy. Materials and methods: medical records of 59 patients with PCa recurrence after radical prostatectomy (pT1-3pN0M0) were analyzed. Biochemical recurrence was observed in 25 (42,4%) and clinical recurrence in 34 (57,6%) patients. Radiotherapy have been prescribed to the regional lymphatic nodes to 44,0 Gy of 2,0 Gy each, to the prostate bed to 66,0 Gy of 2,0 Gy each and if the region of the clinical recurrence was identified - to 72 Gy of 2,0 Gy. Treatment was realized on linear electron accelerators using 3D technology radiotherapy: 3DCRT, IMRT, VMAT. Results: all 59 patients were treated by the «salvage» radiotherapy. Median follow-up was 48 months (24-91). Biochemical control w as achieved in 51 (86.4%) patients, locoregional control in 58 (98.3%) patients. No acute and late grade 3 or greater toxicities were observed.

Redefining the role of adjuvant versus salvage radiation therapy for prostate cancer after radical prostatectomy for T3 disease and/or positive margins.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 367-367
Author(s):  
Barry W. Goy ◽  
In-Lu Amy Liu
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Hormonal Therapy ◽  
Salvage Therapy ◽  
Low Risk ◽  
Adjuvant Radiation ◽  
Positive Margins ◽  
Salvage Radiation Therapy

367 Background: SWOG 8794 recommends adjuvant radiation therapy (ART) after radical prostatectomy (RP) for T3 and/or positive margins. Our purpose was to assess 12-year outcomes on 862 RP patients who had either T3 and/or positive margins who underwent surveillance, salvage radiation therapy (SRT), or hormonal therapy (HT), while categorizing these patients into very low risk (VLR), low risk (LR), high risk (HR), and ultra high risk (UHR) groups. Methods: From 2004 - 2007, 862 RP patients had adverse factors of extracapsular penetration (T3a), seminal vesicle invasion (T3b), positive margins, and/or detectable post-operative PSA. Management included surveillance (54.8%), SRT (36.8%), and HT (8.5%) as first salvage therapy, and 21.5% eventually received hormonal therapy. Twenty patients underwent ART, and were excluded from this analysis. We assessed prognostic factors using multivariable analysis, and 12-year estimates of freedom from biochemical failure (FFBF), freedom from salvage therapy (FFST), distant metastases-free survival (DMFS), prostate cancer-specific survival (PCSS), and overall survival (OS). VLR were those with Gleason Score (GS) of 6. LR were GS 3+4 with only T3a or positive margins, but an undetectable postoperative PSA <0.1. HR were T3b with GS 7-10, any GS 7-10 with T3a/b and positive margins, but an undetectable PSA. UHR were those with a detectable PSA with a GS 7-10. Results: Median follow-up was 12.1 years. Median age was 61.6 years. Median time to first salvage treatment for VLR, LR, HR, and UHR were 10.8, 11.1, 5.3, and 0.6 years, p<0.001. 12-year estimates of FFBF for VLR, LR, HR, and UHR were 60.2%, 52.9%, 28.4%, and 0%, p<0.0001. For FFST, 70.9%, 68.6%, 40.5%, and 0%, p<0.0001. For DMFS, 99.1%, 97.8%, 88.6%, and 63.6%, p<0.0001. For PCSS, 99.4%, 99.5%, 93.5%, and 78.9%, p<0.0001. For OS, 91.8%, 91.8%, 81.0%, and 69.9%, p<0.0001. Conclusions: Outcomes of T3 and/or positive margins using surveillance or SRT as initial management yields excellent outcomes for VLR and LR groups, in which ART should be avoided. For HR, ART can be considered reasonable, since FFBF is only 28.4%. For VHR, these patients may benefit from combined hormonal therapy and ART.

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