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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Age \>18 years

• Clinical stage cT3

• Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy

• Surgical piece management criteria similar to Proteus criteria.

Locations
Other Locations
Italy
ASST Santi Paolo e Carlo
NOT_YET_RECRUITING
Milan
European Institute of Oncology
NOT_YET_RECRUITING
Milan
Istituto Tumori Milano
RECRUITING
Milan
Contact Information
Primary
Valentina Guadalupi, MD
valentina.guadalupi@istitutotumori.mi.it
00390223903811
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 566
Treatments
Other: APA + ADT + RP/RT
Apalutamide 240 mg, four 60 mg tablets as an oral single daily dose, according to clinical practice, plus Androgen Deprivation Therapy (ADT) plus clinician-driven choice local treatment with Radiotherapy or Radical Prostatectomy, six months after starting treatment with apalutamide
Other: APA + ADT
Apalutamide 240 mg, four 60 mg tablets as an oral single daily dose, according to clinical practice, plus Androgen Deprivation Therapy (ADT)
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: ASST Santi Paolo e Carlo, European Institute of Oncology

This content was sourced from clinicaltrials.gov

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