癌研連線CancerLink
招募中 NCT05946213

測試與高風險前列腺癌患者的常規放射治療相比，放射治療的持續時間較短

前列腺癌Phase IIIIII 期IV 期PSMA

這項III期試驗比較了立體定向身體放射治療（ SBRT ） （每次治療在兩週內使用更高劑量進行五次治療）與通常的放射治療（在4至9週內進行20至45次治療） ，用於治療高風險前列腺癌。SBRT使用特殊設備對患者進行定位，並以高精度向腫瘤輸送輻射。這種方法可以在較短的時間內以較少的劑量殺死腫瘤細胞。

適應症：Prostate Adenocarcinoma、Stage III Prostate Cancer AJCC v8、Stage IVA Prostate Cancer AJCC v8

收案條件

納入條件

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • High-risk disease defined as having at least one or more of the following:
  • cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
  • The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
  • Gleason Score of 8-10
  • Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
  • Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
  • No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
  • Age \>= 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior radical prostatectomy
  • No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy)
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease
  • No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
  • Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。