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Compares treatment options for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Official title Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
ClinicalTrials.gov ID: NCT05649943
What this study is testing
What is APA + ADT?
APA + ADT is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic hormone-sensitive prostate cancer (mhspc).
Also referred to as Apalutamide 240 mg + Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2
- No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.
You likely can't join if
- 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...
See the full eligibility 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...
- Able to swallow Apalutamide tablets whole.
- All people 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...
- Age \>18 years
- Clinical stage cT3
- Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy
- Surgical piece management criteria similar to Proteus 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...
- 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...
- Known allergies, hypersensitivity or intolerance to the excipients of Apalutamide.
- Patients who, within 28 days prior to randomisation, have received:
- transfusions (red blood cells and/or platelets);
- hematopoietic growth factors;
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Lombardy, Italy
- Milan, Mi, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Lombardy, Italy; Milan, Mi, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.