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Prostate CancerPhase 2NCT05753566

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

A Phase 2 study testing Rezvilutamide, Androgen deprivation therapy (ADT) and SRT in people with Prostate Cancer and Biochemical Recurrence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Prostate Cancer, Biochemical Recurrence
What is being tested?
Rezvilutamide, Androgen deprivation therapy (ADT) and SRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesChina
Study dates
Mar 2023to Mar 2028
Phase
Phase 2
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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Age ≥ 40 years, male.
  2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
  3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
  4. Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
  5. Biochemical recurrence (two consecutive rises in PSA with absolute values > 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  7. Estimated life expectancy >10 year;
  8. Adequate laboratory parameters
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count (PLT) ≥ 100 x 10^9/L
  • Haemoglobin (Hb) ≥ 90 g/L
  • Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance > 50 ml/min.
  • Total bilirubin (TBIL) ≤ 1.5 x ULN.
  • Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
  • International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .
  • Left ventricular ejection fraction (LVEF) ≥ 50%.
  1. Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
  2. Signed informed consent.

Main Exclusion Criteria:

  1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
  2. Postoperative biochemical recurrence with PSA > 2 ng/ml.
  3. Postoperative pathology containing neuro-endocrine differentiation or small cell features.
  4. Prior malignancy other than prostate cancer in the past three years.
  5. History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
  • Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
  1. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hongqian Guo, phD contact

+86-13605171690

dr.ghq@nju.edu.cn

Shun Zhang, MD contact

+86-15050589789

explorershun@126.com

China2 sites, 2 recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

    Hongqian Guo, Phd, 8613605171690, dr.ghq@nju.edu.cn

    Shun Zhang, MD, 8615050589789, explorershun@126.com

    Recruiting

  • JiangSu Cancer Hospital

    Nanjing, Jiangsu

    Qing Zou

    Not yet recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study

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).

Being tested
Rezvilutamide, Androgen deprivation therapy (ADT), SRT
Keywords
Prostate cancer, Biochemical recurrence, Rezvilutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RezvilutamideDrug

    Also called SHR3680

    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

  • SRTRadiation

    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)

Study groups in NCT05753566
Study groupRoleWhat they receive
Rezvilutamide +ADT+ SRTExperimentalRezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
Receives: Drug: Rezvilutamide; Drug: Androgen deprivation therapy (ADT); Radiation: SRT
Rezvilutamide +ADTExperimentalRezvilutamide along with ADT for 12 cycles (28 days for each cycle)
Receives: Drug: Rezvilutamide; Drug: Androgen deprivation therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year biochemical progression-free survival

    For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/ml)

    Measured: 24 months

  2. 3-year biochemical progression-free survival

    For arm 2, biochemical progression is defined as a confirmed PSA greater than (>) 0.2 ng/ml( the time interval should be over 2 weeks)

    Measured: 36 months

Secondary outcomes (9)

  1. biochemical progression-free survival

    Time from entry to biochemical progression or death due to any cause.

    Measured: 36 months

  2. progression-free survival (PFS)

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

    Measured: 36 months

  3. metastasis-free survival (MFS)

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

    Measured: 36 months

  4. Quality of life as determined by FACT-P scores

    Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores

    Measured: At baseline, 3 months, 6 months, every 3 months up to 3 years

  5. Quality of life as determined by EPIC-26 questionnaire

    Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire

    Measured: At baseline, 3 months, 6 months, every 3 months up to 3 years

  6. Number of Adverse Events

    Number of Adverse Events

    Measured: 36 months

  7. Duration of testosterone recovery

    Duration of testosterone recovery

    Measured: 36 months

  8. Time to testosterone recovery to >50 ng/dl

    Time to testosterone recovery to >50 ng/dl

    Measured: 36 months

  9. Time to testosterone recovery to >300 ng/dl

    Time to testosterone recovery to >300 ng/dl

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study startMar 2023 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753566
Sponsor's protocol ID
IUNU-PC-119
Status last verified
Mar 2023
First submitted
21 Feb 2023
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rezvilutamide, Androgen deprivation therapy (ADT) and SRT in people with Prostate Cancer and Biochemical Recurrence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 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?

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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Hongqian Guo, phD (+86-13605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year biochemical progression-free survival (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753566.

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 6 Mar 2023.

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