Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorFudan University
About this trial
To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT. Maximal cytoreductive therapies consist of 1.cytoreductive radical prostatectomy with/without PLND guided by post-treatment PET 2.metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. All patients receive continuous systemic treatment with apalutamide plus ADT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and willing to sign the informed consent;
Aged ≥18 years;
Histologically or cytologically confirmed prostate adenocarcinoma (primary small cell carcinoma or signet-ring cell carcinoma of the prostate are not allowed, however adenocarcinoma with neuroendocrine differentiation accounting ≤10% is allowed);
Newly diagnosed prostate cancer (within 3 months prior to enrollment);
Disqualifiers
History of allergies, hypersensitivity, or intolerance to any drug used in the study;
Had the contraindications or is intolerant to cRP or RT;
Had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, CT or MRI);
Prior Received any of the following treatments for primary and metastatic prostate cancer;
Trial design
Design model
Single group
Treatments tested in this trial
apalutamide
DrugPatients receive apalutamide 240mg,qd,po.
androgen deprivation therapy
DrugPatients receive systemic ADT.
cytoreductive radical prostatectomy with/without pelvic lymph node dissection
Procedure/SurgeryPatients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
metastasis-directed therapy with radiation
RadiationPatients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: maximal-cytoreductive therapyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL without disease progression or symptomatic deterioration after 6 cycles of study treatment (each cycle is 28 days).
Time frame
At the end of the 6th cycle of treatment (each cycle is 28 days).Secondary outcomes
1
proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL after 3 cycles of study treatment (each cycle is 28 days).
Time frame
At the end of the 3rd cycle of treatment (each cycle is 28 days).2
PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time frame
At the end of the 3rd cycle of treatment (each cycle is 28 days).3
PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time frame
At the end of the 6th cycle of treatment (each cycle is 28 days).4
Conventional imaging and PSMA-PET/CT imaging features at baseline
Imaging features before hormonal therapy
Time frame
Baseline (Before trial treatment)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: