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Prostate CancerPhase 2NCT06305832

Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of 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
Search all trials

Trial summary

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). 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
102 participants
Where
2 sitesChina
Study dates
7 Sep 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

Who may be able to join

  • 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
  • 5. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value \> 0.2ng/ml), and traditional imaging (bone scan and CT/MRI scan) did not show local recurrence and distant metastasis.
  • 6. Have one or more of the following risk factors:
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  • Postoperative CAPRA-S score ≥6 points;
  • The pathological score of radical surgery for prostate cancer was Gleason 8-10;
  • The highest postoperative biochemical recurrence PSA \> 0.5ng/ml;
  • Postoperative pathological stage PT3/T4;
  • PSADT \< 10 months;
  • 7. ECOG status is 0-1;
  • 8. Life expectancy greater than 10 years;
  • 9. Adequate hematological and organ function tests within 4 weeks prior to the first study treatment, as defined below:
  • Neutrophil count (ANC)≥1.5×10^9/L (no granulocyte colony-stimulating factor for 2 weeks prior to cycle 1, day 1);
  • Platelet count (PLT)≥100×10^9/L (no transfusion within 2 weeks prior to day 1 of cycle 1);
  • Hemoglobin (Hb) ≥90g/L
  • Serum creatinine (Cr)≤1.5×ULN or creatinine clearance \> 50ml/min;
  • Total bilirubin (BIL)≤1.5×ULN;
  • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level ≤2.5×ULN;
  • International Standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Left ventricular ejection fraction (LVEF) ≥50%;
  • 10. The subject is willing and understands to sign the informed consent and is able to comply with the agreement.

Who cannot join

  • 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;
  • 5. Known or suspected allergy to reverumide and reverumide excipients;
  • 6. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption;
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  • 7. Have a history of epilepsy, or a medical condition that can induce seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization);
  • 8. Active heart disease in the 6 months prior to C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias;
  • 9. Have had any other malignancies within the 3 years prior to C1D1 (except for carcinoma in situ that has been in complete remission and malignancies that the investigator determined to be slowly progressing);
  • 10. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1;
  • 11. Blood transfusion within 2 weeks before C1D1;
  • 12. Active HBV and HCV infected persons (HBV copy number ≥10^4 copies /mL, HCV copy number ≥10^3 copies /mL);
  • 13. A history of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency diseases) or a history of organ transplantation;
  • 14. Male subjects whose partner is a fertile woman refuse surgical sterilization or use of effective contraception during the trial period and for 3 months after the last dose of riverutamide.
  • 15. The investigator determines subjects who may affect the conduct of clinical studies, who may not be able to comply with the protocol or cooperate with the protocol, and who pose research risks.

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

13605171690

dr.ghq@nju.edu.cn

Shun Zhang, MD contact

15050589789

explorershun@126.com

China2 sites, 2 recruiting

  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

    Nanjing, Jiangsu, 210000

    Shun Zhang, 15050589789 ext. 15050589789, explorershun@126.com

    Recruiting

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

    Nanjing, Jiangsu, 210000

    Hongqian Guo, Phd, 13605171690, dr.ghq@nju.edu.cn

    Shun Zhang

    Recruiting

Other trials in China

About this study

Official title: Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Study

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).

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 NCT06305832
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
ADT+ SRTOtherADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care
Receives: Drug: Androgen deprivation therapy (ADT); Radiation: SRT

What is being measured

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

  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)

    Measured: 48 months

Secondary outcomes (6)

  1. progression-free survival (PFS)

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

    Measured: 48 months

  2. metastasis-free survival (MFS)

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

    Measured: 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

    Measured: 48 months

  4. ctDNA-positive rate

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

    Measured: 48 months

  5. ctDNA clearance rate

    Defined as the number of patients who were ctDNA-positive at enrollment to ctDNA-negative after treatment as a proportion of ctDNA-positive patients enrolled

    Measured: 48 months

  6. Adverse Events

    According to NCI-CTCAE v5.0

    Measured: 48 months

Timeline

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

  1. First posted12 Mar 2024
  2. Study start7 Sep 2023
  3. Primary completionMar 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305832
Sponsor's protocol ID
IUNU-PC-120
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
12 Mar 2024
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?

The sponsor lists 23 inclusion and 15 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 12 Mar 2024. 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 (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?

3-year biochemical progression-free survival (time frame: 48 months). 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 NCT06305832.

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 12 Mar 2024.

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