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@ARTICLE{Spohn:284399,
      author       = {S. K. B. Spohn$^*$ and M. Gainey$^*$ and M. Kamps and C. A.
                      Jilg and C. Gratzke and A. Sigle and M. Mix and B. Ruf$^*$
                      and S. Bürkle and T. Sprave$^*$ and L. Wiehle$^*$ and M.
                      Serpa$^*$ and M. Benndorf and S. Zschaeck and P. Ghadjar and
                      D. Baltas$^*$ and S. Kirste$^*$ and C. Zamboglou and A.
                      Grosu$^*$},
      title        = {{T}oxicity and {P}atient {R}eported {Q}uality of {L}ife
                      after {PSMA}-{PET} and mp{MRT}-{B}ased {F}ocal {D}ose
                      {E}scalated {D}efinitive {R}adiotherapy in {P}rostate
                      {C}ancer {P}atients: 2-{Y}ear {F}ollow-{U}p of the
                      {H}ypo{F}ocal {P}hase {II} {T}rial.},
      journal      = {International journal of radiation oncology, biology,
                      physics},
      volume       = {117},
      number       = {2S},
      issn         = {0360-3016},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier Science},
      reportid     = {DKFZ-2023-01988},
      pages        = {S95},
      year         = {2023},
      abstract     = {The prospective, 2-armed non-randomized HypoFocal phase II
                      trial investigates the safety and feasibility of focal dose
                      escalated external beam radiotherapy (EBRT) and
                      high-dose-rate brachytherapy (HDR-BT) for prostate cancer
                      (PCa) patients based on PSMA-PET and multiparametric MRI.
                      This approach improves tumor coverage and thus putatively
                      treatment effectiveness but leads to larger boost volumes.
                      Here we present toxicity and patient reported quality of
                      life (QoL) results after 2 years follow-up (FU)
                      MATERIALS/METHODS: Patients with intermediate- or high-risk
                      PCa and cN0/cM0 stage were included. Patients in arm A
                      received 60 Gy in 20 fractions to the prostate with an
                      integrated boost of up to 75 Gy. Patients in arm B received
                      one session HDR-BT with 15 Gy to the prostate and a boost of
                      up to 19 Gy, followed by EBRT of 44 Gy in 20 fractions.
                      Boost volumes were defined by PSMA-PET and mpMRI based on
                      validated approaches. Genitourinary (GU) and
                      gastrointestinal (GI) toxicity (CTCAE v5.0) and QoL with
                      IPSS and EORTC questionnaires (QLQ30 and PR25) were
                      assessed.Fifty patients were treated in both arms in two
                      centers (Freiburg and Berlin). Table 1 shows patients
                      characteristics. In arm, A grade 2 GU and GI toxicity rates
                      after 2 years were $8\%$ and $4\%.$ There were no grade 3 GU
                      toxicities. Two patients experienced grade 3 GI toxicities
                      due to multifactorial causes. In Arm B grade 2 GU and GI
                      toxicity rates after 2 years were $17\%$ and $0\%.$ No grade
                      3 toxicities were observed in arm B. Toxicities were not
                      statistically significantly different between baseline and
                      2y FU (p>0.055). QoL analysis was performed with patients
                      with available questionnaires at baseline and 2y FU (12-15
                      in Arm A and 13-15 in Arm B). Only bowel function (p =
                      0.0005, median 4 vs 25 points) in Arm A and sexual- (p =
                      0.016, median 25 vs 50 points) and bowel function (p =
                      0.004, median 0 vs 8 points) and dyspnea (p = 0.031, median
                      0 vs 0 points) in Arm B decreased significantly after 2 year
                      FU. Other QoL items were not significantly different. Bowel
                      symptoms were significantly worse in Arm A compared to Arm B
                      (p = 0.003). Median PSA values after 2 years were 0.23 ng/ml
                      in Arm A and 0.33 ng/ml in Arm B.Despite large boost
                      volumes, the 2 years FU of the HypoFocal-Phase II trials
                      shows no significantly increased GU and GU toxicities
                      compared to baseline symptoms. Patients reported about a
                      good QoL but increased bowel symptoms after 2 years,
                      particularly if treated with EBRT only. Implementation of
                      PSMA-PET into focal dose escalated radiotherapy approaches
                      appears safe and feasible. However, radioproctitis demands
                      careful management. The current PSA values suggest a highly
                      effective therapy, but longer FU is needed to evaluate
                      oncological outcomes. The HypoFocal-SBRT phase III trial
                      will evaluate the PSMA-PET and mpMRI-based focal dose
                      escalated SBRT.},
      cin          = {FR01},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37784612},
      doi          = {10.1016/j.ijrobp.2023.06.427},
      url          = {https://inrepo02.dkfz.de/record/284399},
}