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Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

ConditionsProstate CancerBiochemical Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. ≥40 years old, male;

2. Postoperative pathology showed prostate adenocarcinoma;

3. Postoperative pathological stage pN0 or pNx;

4. PSA decline < 0.1ng/ml within 8 weeks after radical prostate cancer surgery for at least 6 months

Disqualifiers

1. Previously received endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy;

2. Postoperative biochemical recurrence, but PSA more than 2 ng/ml;

3. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features;

4. Is currently participating in or has participated in an investigational drug study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rezvilutamide

    Drug

    Specifications of 80 mg; orally, once a day

  • Androgen deprivation therapy (ADT)

    Drug

    Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator,and the dose and frequency of administration will be consistent with the prescription information

  • SRT

    Radiation

    SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,\~50.4 grays to the pelvis if needed)

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Rezvilutamide +ADT+ SRTExperimental treatment 3 interventions
Group B: ADT+ SRTOther 2 interventions

Trial outcomes

Primary outcomes

1

3-year biochemical progression-free survival

biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml) ( the time interval should be over 2 weeks)

Time frame
48 months

Secondary outcomes

1

progression-free survival (PFS)

Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause

Time frame
48 months
2

metastasis-free survival (MFS)

Time from entry to radiologically confirmed metastasis disease or death due to any cause.

Time frame
48 months
3

percentage of undetectable PSA

percentage of undetectable PSA is defined as the proportion of subjects with a PSA level ≤ 0.1 ng/mL after enrollment

Time frame
48 months
4

ctDNA-positive rate

ctDNA-positive rate was defined as the number of ctDNA subjects detected in the total enrolled population

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov
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