Phase II prospective trial “Give Me Five” short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218)

Marvaso, Giulia; Gugliandolo, Simone Giovanni; Bellerba, Federica; Gandini, Sara; Corrao, Giulia; Volpe, Stefania; Rojas, Damaris Patricia; Riva, Giulia; Zerini, Dario; Pepa, Matteo; Fodor, C.; Rocca, Eliana La; Pricolo, Paola; Alessi, S.; Petralia, Giuseppe; Mistretta, Francesco A.; Cambria, Raffaella; Cattani, Federica; Cobelli, Ottavio De; Orecchia, Roberto; Jereczek‐Fossa, Barbara Alicja

doi:10.1007/s12032-020-01397-3

Cited by 9 publications

(7 citation statements)

References 46 publications

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“…Also, in the "FLAME" trial, Kerkmeijer et al [18] proved that focal boosting the DIL up to 95 Gy in a conventional radiotherapy scheme for 264 patients (vs. 271 patients in the arm without focal boost) improved bDFS and PFS without any relevant additional toxicity. In addition, the preliminary results reported by Marvaso et al [20] in the "GIVE ME FIVE" trial reported very low acute RTOG GU and GI toxic (G2 4.69% and 1.56%, respectively, and only one patient with GU G3 at 6 months) when a dose escalation to 37.5 Gy in 5 fractions was applied as a SIB to the DIL with the VERO ® system.…”

Section: Discussionmentioning

confidence: 96%

“…In our center at the European Institute of Oncology (IEO) IRCCS, Milan, Italy, a high level of expertise has been achieved in the setting of PCa UH-RT, counting more than one thousand patients treated with very low treatment-related toxicities reported [20]. In addition, data for patients receiving UH-RT and simultaneous integrated boost (SIB) on the DIL at IEO has already been published, demonstrating the safety and effectiveness of this treatment [20][21][22].…”

Section: Introductionmentioning

confidence: 99%

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CyberKnife Ultra-Hypofractionated SBRT for Localized Prostate Cancer with Dose Escalation to the Dominant Intraprostatic Lesion: In Silico Planning Study

et al. 2023

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The aim is to evaluate the feasibility of ultra-hypofractionated (UH) SBRT with CyberKnife® (CK) radiosurgery (Accuray Inc., Sunnyvale, California, USA) for localized prostate cancer (PCa) with a concomitant focal boost to the dominant intraprostatic lesion (DIL). Patients with intermediate/high-risk PCa, with at least one visible DIL on multi-parametric MRI, were included. For each, two CK-SBRT in silico plans were calculated using 95% and 85% isodose lines (CK-95%, CK-85%) and compared with the UH-DWA plan delivered with VERO®. All plans simulated a SIB prescription of 40 Gy to PTV-DIL and 36.25 Gy to the whole prostate (PTV-prostate) in five fractions every other day. Fifteen patients were considered. All plans reached the primary planning goal (D95% > 95%) and compliance with organs at risk (OARs) constraints. DVH metrics median values increased (p < 0.05) from UH-DWA to CK-85%. The conformity index of PTV-DIL was 1.00 for all techniques, while for PTV-prostate was 0.978, 0.984, and 0.991 for UH-DWA, CK-95%, and CK-85%, respectively. The CK-85% plans were able to reach a maximum dose of 47 Gy to the DIL while respecting OARs constraints. CK-SBRT plus a focal boost to the DIL for localized PCa appears to be feasible. These encouraging dosimetric results are to be confirmed in upcoming clinical trials such as the phase-II “PRO-SPEED” IEO trial.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

CyberKnife Ultra-Hypofractionated SBRT for Localized Prostate Cancer with Dose Escalation to the Dominant Intraprostatic Lesion: In Silico Planning Study

et al. 2023

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“…SABR has been predominantly explored in low-and intermediaterisk prostate cancer patients, yielding excellent outcomes 10,19,20,21] However, several interrogations persist concerning the optimal dose, target volumes and timing. Interestingly, a relevant question that needs further exploration is the effectiveness of SABR in high-risk patients, especially given the limited number of studies addressing this particular aspect [7,9,11,12,[22][23][24].…”

Section: Discussionmentioning

confidence: 99%

Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial

Zapatero,

Castro,

Roch

et al. 2024

Radiat Oncol

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Background Stereotactic ablative body radiotherapy (SABR) is an emerging treatment alternative for patients with localized low and intermediate risk prostate cancer patients. As already explored by some authors in the context of conventional moderate hypofractionated radiotherapy, focal boost of the index lesion defined by magnetic resonance imaging (MRI) is associated with an improved biochemical outcome. The objective of this phase II trial is to determine the effectiveness (in terms of biochemical, morphological and functional control), the safety and impact on quality of life, of prostate SABR with MRI guided focal dose intensification in males with intermediate and high-risk localized prostate cancer. Methods Patients with intermediate and high-risk prostate cancer according to NCCN definition will be treated with SABR 36.25 Gy in 5 fractions to the whole prostate gland with MRI guided simultaneous integrated focal boost (SIB) to the index lesion (IL) up to 50 Gy in 5 fractions, using a protocol of bladder trigone and urethra sparing. Intra-fractional motion will be monitored with daily cone beam computed tomography (CBCT) and intra-fractional tracking with intraprostatic gold fiducials. Androgen deprivation therapy (ADT) will be allowed. The primary endpoint will be efficacy in terms of biochemical and local control assessed by Phoenix criteria and post-treatment MRI respectively. The secondary endpoints will encompass acute and late toxicity, quality of life (QoL) and progression-free survival. Finally, the subgroup of high-risk patients will be involved in a prospective study focused on immuno-phenotyping. Discussion To the best of our knowledge, this is the first trial to evaluate the impact of post-treatment MRI on local control among patients with intermediate and high-risk prostate cancer undergoing SABR and MRI guided focal intensification. The results of this trial will enhance our understanding of treatment focal intensification through the employment of the SABR technique within this specific patient subgroup, particularly among those with high-risk disease, and will help to clarify the significance of MRI in monitoring local responses. Hopefully will also help to design more personalized biomarker-based phase III trials in this specific context. Additionally, this trial is expected to be incorporated into a prospective radiomics study focused on localized prostate cancer treated with radiotherapy. Trial registration Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. Trial Sponsor IRAD/SEOR (Instituto de Investigación de Oncología Radioterápica / Sociedad Española de Oncología Radioterápica). Study setting Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. Trial status Protocol version number and date: v. 5/ 17 May-2023. Date of recruitment start: August 8, 2023. Date of recruitment completion: July 1, 2024.

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“…The planning target volume of the prostate (PTV-P) was established by applying a systematic expansion of 5 mm in all the directions, except for a 3 mm expansion posteriorly. Similarly, for the planning target volume of the dominant intraprostatic lesion (PTV-DIL), a uniform expansion of 3 mm in all directions was added to CTV-DIL [ 23 ].…”

Section: Case Reportmentioning

confidence: 99%

Cyberknife Radiosurgery for Prostate Cancer after Abdominoperineal Resection (CYRANO): The Combined Computer Tomography and Electromagnetic Navigation Guided Transperineal Fiducial Markers Implantation Technique

Vavassori,

Mauri,

Mazzola

et al. 2023

Current Oncology

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In this technical development report, we present the strategic placement of fiducial markers within the prostate under the guidance of computed tomography (CT) and electromagnetic navigation (EMN) for the delivery of ultra-hypofractionated cyberknife (CK) therapy in a patient with localized prostate cancer (PCa) who had previously undergone chemo-radiotherapy for rectal cancer and subsequent abdominoperineal resection due to local recurrence. The patient was positioned in a prone position with a pillow under the pelvis to facilitate access, and an electromagnetic fiducial marker was placed on the patient’s skin to establish a stable position. CT scans were performed to plan the procedure, mark virtual points, and simulate the needle trajectory using the navigation system. Local anesthesia was administered, and a 21G needle was used to place the fiducial markers according to the navigation system information. A confirmatory CT scan was obtained to ensure proper positioning. The implantation procedure was safe, without any acute side effects such as pain, hematuria, dysuria, or hematospermia. Our report highlights the ability to use EMN systems to virtually navigate within a pre-acquired imaging dataset in the interventional room, allowing for non-conventional approaches and potentially revolutionizing fiducial marker positioning, offering new perspectives for PCa treatment in selected cases.

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Phase II prospective trial “Give Me Five” short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218)

Abstract: Phase II prospective trial "Give Me Five" short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218) Extreme hypofracyionation: impact on QoL

Cited by 9 publications

References 46 publications

CyberKnife Ultra-Hypofractionated SBRT for Localized Prostate Cancer with Dose Escalation to the Dominant Intraprostatic Lesion: In Silico Planning Study

CyberKnife Ultra-Hypofractionated SBRT for Localized Prostate Cancer with Dose Escalation to the Dominant Intraprostatic Lesion: In Silico Planning Study

Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial

Cyberknife Radiosurgery for Prostate Cancer after Abdominoperineal Resection (CYRANO): The Combined Computer Tomography and Electromagnetic Navigation Guided Transperineal Fiducial Markers Implantation Technique

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