Status: Open
Activation Date: 2019APR18
Phase: III
Description: A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]
Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer,(3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 dx less than/= to 5 mets; N1 disease can be included as site of metastases only in patients in relapse after curative intent prostate surgery or radiotherapy (4) Less than/= 3 mets in any non-bone organ system (5) All patients must receive Zoladex (LHRHa),(6)all tumours must be amenable to local ablative therapy (Radiation or surgery),(7) ECOG PS 0-1, (8)patient is medically suitable for all treatment options. EXCLUSION: prior adj/neoadj ADT, unless stopped >12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchymal brain mets.
Objective: Primary objective: To compare failure free survival between patients with oligometastatic HSPC treated with standard systemic therapy plus ablative therapy to untreated prostate primary in patients with low volume metastatic disease burden versus standard systemic therapy plus local ablative therapy to all sites of disease. Secondary objectives: Radiographic Progression Free Survival; Incidence of new metastases as first event; Overall survival; Ablative treatment related adverse events (grade 3 or greater); Quality of Life (QOL); Economic analysis. Tertiary objectives: Correlative exploratory studies such as immunophenotyping to understand mechanisms of resistance to SBRT when added to standard systemic therapy and identify predictive/prognostic markers in the trial population, and to create a biorepository of tissue and blood for future correlative studies.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects of standard treatment to standard treatment plus ablative therapy (Radiotherapy or surgery) to all sites of disease in patients with oligometastatic hormone sensitive prostate cancer. It is not clear if ablative therapy (SBRT for example) to all sites of disease used in combination with standard treatments such as hormone therapy and/or chemotherapy can offer better results than standard treatment alone. This study will also obtain important information about the effects of treatment on quality of life, cost effectiveness, as well as predictive and prognostic correlative markers.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GENITO-URINARY | PR20 | Open Trial | 164 | 148 | 299 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GENITO-URINARY | PR20 | Open Trial | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
GENITO-URINARY | PR20 | Open Trial | 343 | 0 | 0 | 0 | 342 | 0 | 0 | 0 |