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NCT Number: NCT07477626

Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy.

The main questions it aims to answer are:

* Does ADT combined with pelvic radiotherapy improve biochemical recurrence-free survival (bRFS) compared with ADT alone in pN1 patients? * Does the addition of pelvic radiotherapy improve clinical progression-free survival, metastasis-free survival, overall survival, and prostate cancer-specific survival without unacceptable toxicity?

Researchers will compare ADT plus pelvic radiotherapy with ADT alone to see if combined treatment improves disease control and long-term clinical outcomes.

Participants with positive lymph nodes after prostatectomy will be randomly assigned in a 2:1 ratio to receive ADT plus pelvic radiotherapy, or ADT alone. ADT will be administered for 2 years. Patients with radiologically detectable pelvic recurrence or distant metastases after radical prostatectomy will be excluded. Safety, adverse events, and health-related quality of life will be assessed during follow-up.

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Key information

Conditions

Prostate Cancer (Post Prostatectomy) Androgen Deprivation Therapy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lymph Node Positive Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Non-Metastatic Prostatic Diseases Prostatic Neoplasms Radiotherapy; Image-Guided Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dongguan People's Hospital, Dongguan, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and/or perirectal nodes).
  • ECOG performance status 0-2.
  • Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy*.
  • Adequate major organ function, defined as:

Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN

  • Use of effective contraception during the study and for 3 months after.
  • Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.
  • Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.

Exclusion criteria

  • Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).
  • Radiographically confirmed distant metastasis (M1a, M1b, or M1c).
  • Neoadjuvant hormonal therapy > 3 months before prostatectomy.
  • Malignancy within 5 years that may interfere with study safety or efficacy assessments.
  • Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
  • Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
  • Serious comorbidities affecting study treatment.
  • Psychiatric disorders preventing understanding or compliance.
  • Any condition that, in the investigator's judgment, makes participation unsuitable.

Treatment and study plan

Androgen deprivation therapy (ADT)

Drug

Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed.

Radiotherapy

Radiation

Radiotherapy will be administered using IMRT or VMAT techniques. Radiation fields will include the pelvic lymph node drainage areas, with inclusion of the prostate bed in patients with pT3-4 disease or positive surgical margins.

Primary outcomes

  1. Biochemical progression-free survival

    Time frame: 5 years

    Time from randomization to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause.

Secondary outcomes

  1. Clinical recurrence-free survival

    Time frame: 5 years

    The time from randomization to first radiographic progression or death from any cause.

  2. Locoregional failure free survival

    Time frame: 5 years

    The time from randomization to the first occurrence of locoregional recurrence (prostate bed or pelvic lymph nodes) or death from any cause.

  3. Metastasis-free survival

    Time frame: 5 years

    The time from randomization to the first occurrence of distant metastasis (excluding pelvic lymph nodes) or death from any cause.

  4. Post-operative biochemical progression-free survival

    Time frame: 5 years

    Time from surgery to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause.

  5. Freedom from non-protocol hormone therapy

    Time frame: 5 years

    Time from randomization to initiation of non-protocol-specified hormonal therapy, including additional hormonal agents or re-initiation of castration therapy without meeting progression criteria.

  6. Freedom from castration resistance survival

    Time frame: 5 years

    Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria.

  7. Overall survival

    Time frame: 5 years

    The time from randomization to death from any cause.

  8. Prostate cancer-specific survival

    Time frame: 5 years

    The time from randomization to death directly attributable to prostate cancer.

  9. Adverse Events

    Time frame: 5 years

    Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  10. Health-Related Quality of Life

    Time frame: 5 years

    Changes from baseline in global health status and functional/symptom scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

  11. Prostate Cancer-Specific Quality of Life

    Time frame: 5 years

    Changes from baseline in prostate cancer-specific quality of life measured using the EORTC QLQ-PR25 module.

  12. Anxiety and Depression

    Time frame: 5 years

    Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).

Study contacts

Contact information is provided by the study sponsor or research team.

Liru He, PhD

CONTACT

[email protected]

+862087343030

Yang Liu, MD

CONTACT

[email protected]

+862087341521

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Radiotherapy and Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Alone After Prostatectomy for Node Positive Prostate Cancer (RADVAN): A Multicenter, Randomized Controlled Phase Ⅲ Trial

Acronym: RADVAN

Important dates

Study start
2026
Primary completion
2033
Study completion
2038
First posted
Mar 17, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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