Combination treatment for metastatic hormone-sensitive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Italian multicenter study aims to enroll approximately 566 patients with oligometastatic hormone-sensitive prostate cancer who are eligible for treatment with apalutamide. After six months of treatment, participants will be randomized to receive either local treatment (radiotherapy or prostatectomy) alongside apalutamide and androgen deprivation therapy (ADT), or to continue with apalutamide and ADT alone. The primary endpoint is to assess the efficacy of the combined treatment in terms of radiographic progression-free survival, while secondary endpoints include evaluating tumor shrinkage, side effects, and overall survival. The study seeks to determine the best approach to improve patient outcomes in this specific cancer population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.
* No previous systemic or local treatment for prostate adenocarcinoma, including pelvic radiotherapy.
* Laboratory values at the time of screening:

  a. Neutrophils ≥ 1500/μL b. Hemoglobin ≥ 9.0 mg/μL (no transfusions in the past 28 days) c. Platelets ≥ 100,000/μL d. Creatinine ≤ 2 x upper limit of normal and serum albumin ≥ 3.0 g/dL f. Total bilirubin ≤ 1.5 x upper limit of normal \[NOTE: In subjects with Gilbert syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN subjects may be eligible\]; g. AST and ALT ≤ 2.5 x upper limit of normal
* Able to swallow Apalutamide tablets whole.
* All subjects must sign an Informed Consent Form indicating that they understand the purpose of the study and its procedures and intend to participate. The subject must be willing and must be able to comply with the restrictions specified in this protocol.

Inclusion criteria for cytoreductive surgery:

* Age \>18 years
* Clinical stage cT3
* Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy
* Surgical piece management criteria similar to Proteus criteria.

Exclusion Criteria:

* Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.
* Known brain metastases.
* Lymph node metastases only.
* Visceral metastases.
* Patients not eligible for surgery or radiotherapy.
* Unacceptable increase in cardiovascular risk, defined as the occurrence of at least one of the following episodes in the 6 months prior to randomization: unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant thromboembolic events (e.g., pulmonary embolism), or clinically significant ventricular arrhythmias .
* Uncontrolled high blood pressure (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
* Previous treatment with antiandrogens, GnRH analogues, or other systemic treatments for adenocarcinoma of the prostate.
* Previous local treatment with surgery and/or radiotherapy.
* Any prior malignancy (except adequately treated basal cell carcinoma or a squamous cell skin carcinoma, superficial bladder carcinoma, or any other in situ carcinoma currently in complete remission) within 5 years of randomization.
* Known allergies, hypersensitivity or intolerance to the excipients of Apalutamide.
* Patients who, within 28 days prior to randomisation, have received:

  1. transfusions (red blood cells and/or platelets);
  2. hematopoietic growth factors;
  3. major surgery.
* Symptomatic and/or chronic viral hepatitis; chronic liver disease; moderate or severe liver failure (class B and C according to the Child-Pugh scale); encephalopathy, ascites or thrombo-haemorrhagic disorders secondary to liver failure.
* Gastrointestinal disorders affecting drug absorption
* Active infections requiring systemic therapy such as human immunodeficiency virus (HIV);
* Any condition or situation which, in the judgment of the investigator, precludes participation in this trial.

Exclusion criteria for cytoreductive surgery:

* Contraindication for surgery

Where it's running

• Istituto Tumori Milano
  Milan, Mi, Italy Recruiting
• European Institute of Oncology
  Milan, Lombardy, Italy Not yet recruiting
• ASST Santi Paolo e Carlo
  Milan, Lombardy, Italy Not yet recruiting

Study contacts

• Principal investigator: Valentina Guadalupi, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study coordinator: Valentina Guadalupi, MD
• Email: valentina.guadalupi@istitutotumori.mi.it
• Phone: 00390223903811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Saruparib plus physician’s ARPI choice vs placebo in men with metastatic hormone-sensitive prostate cancer previously treated with docetaxel or Lu-PSMA

  This study tests whether adding saruparib to a physician’s choice of ARPI helps men with metastatic hormone-sensitive prostate cancer who have already had docetaxel or Lu-PSMA therapy and no progression, compared with placebo plus ARPI.

  Recruiting at 6 sites Phase 3 AstraZeneca · Hot Springs, Arkansas and 209 other locations · NCT07711002

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• How darolutamide with hormone therapy works for advanced prostate cancer in German practice

  This observational study looks at how well darolutamide added to hormone therapy works for German men with metastatic hormone-sensitive prostate cancer who are already starting this combination in routine care.

  Recruiting Bayer · Locations · NCT07395804

• Rezvilutamide versus enzalutamide for low-volume metastatic hormone-sensitive prostate cancer

  This Phase III trial tests whether rezvilutamide works as well as or better than enzalutamide for men with low-volume metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy.

  Recruiting Phase 3 Jiangsu HengRui Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07241416

• PSA‑triggered intermittent relugolix plus ARPI for metastatic hormone‑sensitive prostate cancer

  This trial will test whether taking relugolix with an androgen receptor pathway inhibitor on an intermittent schedule based on PSA levels works for men with metastatic hormone‑sensitive prostate cancer who achieve a strong PSA response.

  Recruiting Phase 2 University of Utah · Salt Lake City, Utah · NCT07216248

• Tulmimetostat with darolutamide or abiraterone for metastatic hormone-sensitive prostate cancer

  This trial will test whether adding tulmimetostat to darolutamide or abiraterone helps men with metastatic hormone-sensitive prostate cancer control their cancer better.

  Recruiting at 30 sites Phase 1/2 Novartis · Birmingham, Alabama and 30 other locations · NCT07190300

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.