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Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.
Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Androgen Deprivation therapy and Apalutamide |
|
| Treatment | Experimental | Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT on all sites of metastatic disease+Apalutamide | Combination Product | oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete biochemical response | Rate of patients with complete biochemical response (PSA < 0.2 ng/ml) | 6 months after treatment start. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biochemical progression | Biochemical progression defined according to Prostate Cancer Working Group Criteria | 2 years after treatment |
| Freedom from radiological progression | radiological progression defined according to Prostate Cancer Working Group Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi Radiation Oncology Unit | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32484754 | Background | Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2. | |
| 34246347 |
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Patients will be randomized between control arm (Androgen Deprivation therapy and Apalutamide) or treatment arm (Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease)
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| 2 years after treatment |
| Rate of adverse events | measured according to Common Terminology Criteria for Adverse Events | 2 years after treatment |
| Overall Survival | Time between randomization and death from any cause | 2 years after treatment |
| Cancer Specific Survival | Time between randomization and death from prostate cancer | 2 years after treatment |
| Health related quality of life | Measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. | 2 years after treatment |
| Health related quality of life | Measured with EORTC QLQ-PR25 questionnaire | 2 years after treatment |
| Background |
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| 33914595 | Result | Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29. |