Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID05649943

Multimodal Approach in Patients With Metastatic Hormone-Sensitive Prostate Cancer: A Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy Versus Apalutamide Plus Androgen Deprivation Therapy and Local Treatment

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-09-03

566

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

F

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead Sponsor

A

ASST Santi Paolo e Carlo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating treatment options for men with metastatic hormone-sensitive prostate cancer. This Italian multicenter study aims to compare the effectiveness of apalutamide combined with androgen deprivation therapy (ADT) followed by local treatment versus apalutamide plus ADT alone. The goal is to see if adding radiotherapy or radical prostatectomy after 6 months improves the time patients live without cancer progression seen on scans. Participants will all start with apalutamide tablets taken daily along with ADT. After 6 months, they will be randomly assigned to either continue medical therapy alone or receive additional local treatment chosen by their doctor, including radiotherapy or surgery. Radiotherapy involves specific doses over several weeks, and surgery is planned to occur about 6 months after starting apalutamide. During the study, patients will be monitored for cancer progression using scans and clinical assessments up to 48 months. Researchers will also evaluate tumor shrinkage, side effects, time until cancer becomes resistant to hormones, survival outcomes, and quality of life using questionnaires. Participants will be followed closely with regular visits and tests to record these outcomes and ensure safety throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Histologically confirmed prostate adenocarcinoma diagnosis
  • Metastatic disease with at least one bone lesion confirmed by bone scan and CT or MRI if only one lesion
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade 2 or less
  • No previous antiandrogen or GnRH analogue treatment, or treatment lasting 3 months or less
  • No previous systemic or local prostate cancer treatment including pelvic radiotherapy
  • Laboratory values at screening: neutrophils ≥ 1500/µL, hemoglobin ≥ 9.0 mg/µL without recent transfusions, platelets ≥ 100,000/µL, creatinine ≤ twice upper normal limit, serum albumin ≥ 3.0 g/dL, total bilirubin ≤ 1.5 times upper limit unless Gilbert syndrome criteria met, AST and ALT ≤ 2.5 times upper limit
  • Able to swallow apalutamide tablets whole
  • Signed informed consent and willingness to comply with study protocol
  • For cytoreductive surgery: age over 18 years, clinical stage cT3, planned robot-assisted radical prostatectomy with lymphadenectomy, surgical management per Proteus criteria
Not Eligible

You will not qualify if you...

  • Small cell, ductal, or neuroendocrine prostate cancer pathology
  • Known brain metastases
  • Lymph node metastases only
  • Visceral metastases
  • Ineligibility for surgery or radiotherapy
  • Unacceptable cardiovascular risk including recent unstable angina, heart attack, heart failure, thromboembolic events, or serious arrhythmias
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Previous treatment with antiandrogens, GnRH analogues, or systemic prostate cancer therapies
  • Previous local treatment with surgery or radiotherapy
  • Prior malignancy within 5 years except certain treated skin or in situ carcinomas
  • Allergies or intolerance to apalutamide excipients
  • Recent blood transfusions, hematopoietic growth factors, or major surgery within 28 days
  • Symptomatic or chronic viral hepatitis, chronic liver disease, moderate or severe liver failure, or related complications
  • Gastrointestinal disorders affecting drug absorption
  • Active infections requiring systemic therapy including HIV
  • Any condition judged by investigator to prevent trial participation
  • Contraindications for cytoreductive surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months of apalutamide and ADT, followed by local treatment lasting 4 weeks for radiotherapy or a single surgery procedure

Participants receive daily oral apalutamide combined with androgen deprivation therapy. After 6 months of apalutamide treatment, some participants will also receive local treatment with either radiotherapy or radical prostatectomy as determined by their clinician.

Daily oral medication and for those receiving radiotherapy, weekly visits for up to 6 weeks; surgery is a one-time procedure

Follow-up

Duration - Up to 48 months

Participants are monitored for radiographic progression, tumor response, side effects from treatment, and overall survival for up to 48 months after treatment.

Periodic visits for monitoring during follow-up

Trial Site Locations

Total: 3 locations

1

European Institute of Oncology

Milan, Lombardy, Italy, 20141

Not Yet Recruiting

2

ASST Santi Paolo e Carlo

Milan, Lombardy, Italy, 20153

Not Yet Recruiting

3

Istituto Tumori Milano

Milan, Mi, Italy, 20156

Actively Recruiting

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Research Team

V

Valentina Guadalupi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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Gwenaelle Gravis, Jean-Marie Boher, Florence Joly...

https://pubmed.ncbi.nlm.nih.gov/26610858

Treatment results of radiotherapy to both the prostate and metastatic sites in patients with bone metastatic prostate cancer.

Koji Inaba, Keisuke Tsuchida, Tairo Kashihara...

https://pubmed.ncbi.nlm.nih.gov/33822986

Cytoreductive radical prostatectomy in patients with prostate cancer and low volume skeletal metastases: results of a feasibility and case-control study.

Axel Heidenreich, David Pfister, Daniel Porres

https://pubmed.ncbi.nlm.nih.gov/25254935

Might men diagnosed with metastatic prostate cancer benefit from definitive treatment of the primary tumor? A SEER-based study.

Stephen H Culp, Paul F Schellhammer, Michael B Williams

https://pubmed.ncbi.nlm.nih.gov/24290503

A Multi-institutional Analysis of Perioperative Outcomes in 106 Men Who Underwent Radical Prostatectomy for Distant Metastatic Prostate Cancer at Presentation.

Prasanna Sooriakumaran, Jeffrey Karnes, Christian Stief...

https://pubmed.ncbi.nlm.nih.gov/26038098