Clinical trial NCT05717582: Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Official title: A Prospective Study of Maximal-Cytoreductive Therapies for Patients With de Novo Metastatic Hormone-sensitive Prostate Cancer Who Achieve Oligopersistent Metastases During Systemic Treatment With Apalutamide Plus ADT (CHAMPION Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Castration-Sensitive Prostate Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Able to understand and willing to sign the informed consent;
2. Aged ≥18 years;
3. 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);
4. Newly diagnosed prostate cancer (within 3 months prior to enrollment);
5. M1a/b disease with the presence of 1-10 visible metastases at diagnosis by conventional imagine including bone scan (ECT) and CT or MRI of the chest, abdomen, and pelvis;
6. With initial systemic treatment of apalutamide plus ADT and willing and expected to comply with treatment and follow up schedule \[No more than 2-month systemic treatment before enrollment (including ADT and ADT combined with short-term first-generation anti-androgen therapy (flutamide or bicalutamide); To maximize enrollment, patients who had started apalutamide plus ADT before enrollment are allowed into the study provided that they are otherwise eligible and therapy was initiated no longer than 2 months before enrollment\];
7. Fit to undergo cytoreductive radical prostatectomy and radiotherapy to the visible sites of metastases;
8. ECOG PS score is 0-1;
9. Adequate organ function;
10. Life expectancy ≥ 12 months.

Exclusion Criteria:

1. History of allergies, hypersensitivity, or intolerance to any drug used in the study;
2. Had the contraindications or is intolerant to cRP or RT;
3. Had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, CT or MRI);
4. Prior Received any of the following treatments for primary and metastatic prostate cancer;

   1. \>2-month ADT or first-generation antiandrogens (bicalutamide, flutamide etc.);
   2. Any other novel hormonal therapies (enzalutamide, darolutamide, abiraterone etc.) except ≤ 2-month apalutamide plus ADT listed in inclusion criteria;
   3. Any chemotherapy;
   4. local treatment or metastatic treatment for primary prostate cancer or metastases;
   5. Any immunotherapy (PD-L1 etc.), target therapy (PARPi etc), etc;
5. History of seizure or known condition that may predispose to seizure;
6. History of major surgery 4 weeks before enrollment;
7. Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study;
8. Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. );
9. Conditions of active infection;
10. History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years;
11. Patients who is currently undergoing other trials;
12. Unwilling or difficult to cooperate with treatment and follow-up visit;
13. Other sever conditions which could interfere with trial safety or results judged by the investigator.

Primary outcomes:
measure: proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).
timeFrame: At the end of the 6th cycle of treatment (each cycle is 28 days).
Secondary outcomes:
measure: proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
timeFrame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
measure: PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days).
timeFrame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
measure: PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
timeFrame: At the end of the 6th cycle of treatment (each cycle is 28 days).
measure: Conventional imaging and PSMA-PET/CT imaging features at baseline
timeFrame: Baseline (Before trial treatment)
measure: Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
timeFrame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
measure: Comparison of imaging features between conventional imaging and PSMA PET/CT.
timeFrame: At the end of the 3rd and 6th cycle of treatment (each cycle is 28 days).
measure: Feasibility and safety of performing cRP±MDT treatment
timeFrame: At the end of the 6th cycle of treatment (each cycle is 28 days).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center Pudong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center Xuhui Hospital
state: Shanghai
Study officials:
References: