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

NCT05649943 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

APA + 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.

PROCEDURE

Local 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).

Sponsors & Collaborators

  • ASST Santi Paolo e Carlo

    collaborator OTHER

  • European Institute of Oncology

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Valentina Guadalupi, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2027-01-01
Completion
2029-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649943 on ClinicalTrials.gov