RecruitingNot ApplicableNCT05649943

Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment

APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

566 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding local treatment (surgery or radiation) to the primary prostate tumor — in addition to hormonal therapy and a newer drug called apalutamide — improves survival in men with prostate cancer that has spread to the bones. **You may be eligible if...** - You are 18 or older with prostate cancer confirmed by biopsy - Your cancer has spread to at least one bone lesion - You have a good performance status and adequate organ function **You may NOT be eligible if...** - Your cancer has spread widely to many sites or to organs - You have had prior hormonal therapy for metastatic disease - You have significant other health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPA + ADT

All 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.

PROCEDURELocal Treatmetn RT or RP

Patients 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).