Italian multicenter study, will enroll \~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.
After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.
Age > 18
Histologically confirmed diagnosis of prostate adenocarcinoma
Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2
Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.
Known brain metastases.
Lymph node metastases only.
Visceral metastases.
Parallel
APA + ADT
DrugAll participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily. Apalutamide is distributed in Italy under the trade name of Erleada® 60 mg. All patients not undergoing surgical castration should also continue medical castration by taking a gonadotropin-releasing hormone (GnRHa) analogue during treatment.
Local Treatmetn RT or RP
Procedure/SurgeryPatients who will undergo radiotherapy as a local treatment must be treated according to the following scheme: External beam radiotherapy administered at 36 Gy in six consecutive weekly fractions of 6 Gy, or 55 Gy in 20 daily fractions of 2・75 Gy over 4 weeks. Radiation therapy will be given with the patient supine and with a full bladder and an empty rectum. The planned target volume is prostate only, with an 8 mm margin posteriorly and a 10 mm margin elsewhere. No RT on lymph nodes is foreseen. RT should begin 6 months after the first dose of apalutamide (+/- 2 weeks). Radical prostatectomy should be performed 6 months after the first dose of apalutamide (+/- 2 weeks).
Radiographic Progression-Free Survival (rPFS)
Evaluation of the efficacy of treatment with APA+ADT for 6 months followed by locoregional treatment with radiotherapy or radical prostatectomy compared to treatment with APA+ ADT alone in terms of Radiographic Progression-Free Survival (rPFS) in patients with hormone prostate adenocarcinoma -susceptible with low-volume metastatic disease.
Local event - free survival
Defined as the absence of one of the following conditions in the follow up: urinary retention, hydronephrosis, acute or chronic renal failure exacerbation, intestinal obstruction
Local treatment - free survival
Defined as the absence of the need for one of the following interventions: trans-urethral resection of the prostate, placement of a ureteral stent or nephrostomy for hydronephrosis, bladder catheterization, surgery for intestinal obstruction/colostomy
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
ASST Santi Paolo e Carlo
Collaborator
European Institute of Oncology
Collaborator
