Prostate Cancer (Post Prostatectomy)Phase 3RADVANNCT07477626
Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
A Phase 3 study testing Androgen Deprivation Therapy (ADT) and radiotherapy in people with Prostate Cancer (Post Prostatectomy) and Radiotherapy; Image-Guided, run by Sun Yat-sen University at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic
- What is being tested?
- Androgen Deprivation Therapy (ADT) and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 13 sitesChina
- Study dates
- 20 Mar 2026to 31 Dec 2038
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- Serious comorbidities affecting study treatment.
- Psychiatric disorders preventing understanding or compliance.
- Any condition that, in the investigator's judgment, makes participation unsuitable.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Hospital
Beijing
Qiuzi Zhong, +861085132266, drzhongqiuzi@163.com
- Not yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Ningning Lu, +861087787388, Ning-Ning.Lu@hotmail.com
- Recruiting
Peking University First Hospital
Beijing
Hongzhen Li, +861083572211, hongzhen.li@pkufh.com
- Not yet recruiting
Peking University Third Hospital
Beijing
Hao Wang, +861082264204, wanghaobysy@bjmu.edu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Yali Shen, +862885422114, sylprecious@163.com
- Not yet recruiting
Dongguan People's Hospital
Dongguan, Guangdong
Xuefang Zhang, Dr., +86-0769-28637333, xuefang00000@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yang Liu, MD, +862087341521, liuyang1@sysucc.org.cn
Liru He, PhD, +862087343030, helir@sysucc.org.cn
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Jiancong Sun, Dr., +86-20-83337750, sunjiancong@126.com
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yan Wang, Dr., +86-020-87755766, wangyan7@mail.sysu.edu.cn
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Senxiang Yan, +8657187236413, yansenxiang@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Naval Medical University
Shanghai
Huojun Zhang, +862131166666, chyyzhj@163.com
- Not yet recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Zhennan Wang, +867592387612, zhennan_wang163@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Wen Wang, Dr., +86-400-0371-818
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic, Androgen Deprivation Therapy, Lymph Node Positive
- Being tested
- Androgen Deprivation Therapy (ADT), radiotherapy
- Keywords
- prostate cancer, node positive, pN1, radiotherapy, androgen deprivation therapy, hormone therapy, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy arm | Experimental | Patients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years. Receives: Drug: Androgen Deprivation Therapy (ADT); Radiation: radiotherapy |
| ADT arm | Active comparator | Patients will receive androgen deprivation therapy alone for 2 years. Receives: Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical progression-free survival
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.
Measured: 5 years
Secondary outcomes (12)
Clinical recurrence-free survival
The time from randomization to first radiographic progression or death from any cause.
Measured: 5 years
Locoregional failure free survival
The time from randomization to the first occurrence of locoregional recurrence (prostate bed or pelvic lymph nodes) or death from any cause.
Measured: 5 years
Metastasis-free survival
The time from randomization to the first occurrence of distant metastasis (excluding pelvic lymph nodes) or death from any cause.
Measured: 5 years
Post-operative biochemical progression-free survival
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.
Measured: 5 years
Freedom from non-protocol hormone therapy
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.
Measured: 5 years
Freedom from castration resistance survival
Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria.
Measured: 5 years
Overall survival
The time from randomization to death from any cause.
Measured: 5 years
Prostate cancer-specific survival
The time from randomization to death directly attributable to prostate cancer.
Measured: 5 years
Adverse Events
Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: 5 years
Health-Related Quality of Life
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).
Measured: 5 years
Prostate Cancer-Specific Quality of Life
Changes from baseline in prostate cancer-specific quality of life measured using the EORTC QLQ-PR25 module.
Measured: 5 years
Anxiety and Depression
Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Mar 2026
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Liru He, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477626
- Sponsor's protocol ID
- 2025-FXY-409
- Other IDs
- B2025-816
- Acronym
- RADVAN
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to local law
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07477626
- Acronym / sponsor ID
- RADVAN / 2025-FXY-409
- Conditions
- Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic, Androgen Deprivation Therapy, Lymph Node Positive
- Keywords
- prostate cancer, node positive, pN1, radiotherapy, androgen deprivation therapy, hormone therapy, prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy arm | Experimental | Drug: Androgen Deprivation Therapy (ADT), Radiation: radiotherapyPatients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years. |
| ADT arm | Active comparator | Drug: Androgen Deprivation Therapy (ADT)Patients will receive androgen deprivation therapy alone for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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*.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation Therapy (ADT)Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed. | Drug | ADT arm, Radiotherapy arm |
| radiotherapyRadiotherapy 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. | Radiation | Radiotherapy arm |
Primary outcome
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.
12 secondary outcomes
Clinical recurrence-free survival
Time frame: 5 years
Locoregional failure free survival
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Post-operative biochemical progression-free survival
Time frame: 5 years
Freedom from non-protocol hormone therapy
Time frame: 5 years
Freedom from castration resistance survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Prostate cancer-specific survival
Time frame: 5 years
Adverse Events
Time frame: 5 years
Health-Related Quality of Life
Time frame: 5 years
Prostate Cancer-Specific Quality of Life
Time frame: 5 years
Anxiety and Depression
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Due to local law
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SURPASS: Stereotactic Ultra-hypofractionated Radiotherapy for Post-prostatectomy Patients: Adaptive Salvage SBRT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liru He, PhD principal investigator
Sun Yat-Sen University Cancer Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Androgen Deprivation Therapy (ADT) and radiotherapy in people with Prostate Cancer (Post Prostatectomy) and Radiotherapy; Image-Guided, run by Sun Yat-sen University at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liru He, PhD (+862087343030, helir@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.