Feasibility and Optimal Time Point of [68Ga]Gallium-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography Imaging in Patients Undergoing Cytoreductive Surgery After Systemic Therapy for Primary Oligometastatic Prostate Cancer: Implications for Patient Selection and Extent of Surgery

Huebner, Nicolai; Rasul, Sazan; Baltzer, Pascal; Clauser, Paola; Grubmüller, Karl Hermann; Mitterhauser, Markus; Hacker, Marcus; Heidenreich, Axel; Rajwa, Paweł; Fajković, Harun; Shariat, Shahrokh F.; Grubmüller, Bernhard

doi:10.1016/j.euros.2022.04.003

Cited by 2 publications

(2 citation statements)

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“…Additionally, PSMA-PET is insufficient to detect micrometastasis (<5 mm), and the impact of systemic therapy on PSMA-PET imaging results is currently unclear; it is, however, likely to impair its accuracy. 41 …”

Section: Diagnostics Of Oligometastatic Prostate Cancermentioning

confidence: 99%

The current role of precision surgery in oligometastatic prostate cancer

et al. 2022

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Section: Diagnostics Of Oligometastatic Prostate Cancermentioning

confidence: 99%

The current role of precision surgery in oligometastatic prostate cancer

et al. 2022

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“…Therefore, the value of PSMA PET/CT for newly diagnosed mHSPC still needs to be evaluated by its application during natural disease course. In a prospective trial, about 63% of newly diagnosed oligometastatic prostate cancer cases had a complete radiological response to systemic therapy plus pelvic lymph node dissection [PLMD] guided by PSMA PET/CT and 47% of cases had a pathological complete response, suggesting the potential value of PSMA PET/ CT in treatment evaluation and decision-making [24]. Furthermore, a previous study by our group found that about 50% of nonmetastatic castration-resistant prostate cancer on conventional imaging has been proved to be metastatic on PSMA PET/CT, and the incidence of metastatic disease was less frequent in patients who received SBRT compared with those who did not [25].…”

Section: Introductionmentioning

confidence: 99%

Protocol for CHAMPION study: a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy

Wang,

Pan,

Zhang

et al. 2024

BMC Cancer

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Background The proposed trial is to examine the feasibility of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)-guided cytoreduction plus apalutamide and androgen deprivation therapy (ADT) for newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) at oligometastatic state. Methods CHAMPION (NCT05717582) is an open-label, single-arm, phase II trial, planning to enroll newly diagnosed mHSPC cases with oligometastases (≤ 10 distant metastatic sites in conventional imaging). Patients will receive 6 cycles of apalutamide plus ADT. Patients with oligometastatic disease at PSMA PET/CT after 3 treatment cycles will receive cytoreductive radical prostatectomy. PSMA PET/CT-guided metastasis-directed external radiation therapy will be determined by the investigators. Apalutamide plus ADT will be continued for 2 weeks postoperatively. The primary endpoint is the proportion of patients with undetectable prostate-specific antigen (PSA), no disease progression, and no symptom deterioration after 6 cycles of apalutamide plus ADT. Secondary endpoints include the percentage of patients with PSA ≤ 0.2 ng/mL and oligometastases by the end of 3 treatment cycles, PSA response rate, and safety. Fleming’s two-stage group sequential design will be adopted in the study, where the null hypothesis is that the rate of patients with an undetectable PSA is ≤ 40% after 6 cycles of treatment, while the alternate hypothesis is an undetectable PSA of > 60%; with one-sided α = 0.05, power = 0.80, and an assumed dropout rate of 10%, the required number of patients for an effective analysis is 47. Enrolment in the study commenced in May 2023. Discussion The multi-modal therapy based on treatment response may improve the prognosis of newly diagnosed mHSPC patients with oligometastases. Trial registration The study is registered with Clinical Trials.Gov (NCT05717582). Registered on 8th February 2023.

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Cited by 2 publications

References 29 publications

The current role of precision surgery in oligometastatic prostate cancer

The current role of precision surgery in oligometastatic prostate cancer

Protocol for CHAMPION study: a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy

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