Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

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 rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).

Eligibility criteria

Qualifiers

Age ≥ 40 years, male.

Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.

pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);

Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;

Disqualifiers

Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .

Postoperative biochemical recurrence with PSA > 2 ng/ml.

Postoperative pathology containing neuro-endocrine differentiation or small cell features.

Prior malignancy other than prostate cancer in the past three years.

Trial design

Treatments tested in this trial

  • Rezvilutamide
  • Androgen deprivation therapy (ADT)
  • SRT

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators