Prostate CancerPhase 1/2COPRA424NCT07765940
Safety and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 in Prostate Cancer
A Phase 1/2 study testing [⁶⁴Cu]Cu-RAX301 Injection in people with Prostate Cancer, run by RadAlliance Therapeutics, Inc.
Trial summary
This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and preliminary diagnostic performance of [⁶⁴Cu]Cu-RAX301 Injection in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [⁶⁴Cu]Cu-RAX301 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I
- Participants must meet all of the following criteria to be eligible for enrollment:
- Able to provide written informed consent prior to initiation of any study-specific procedures.
- Male participants aged ≥18 years.
- Histologically confirmed prostate cancer.
- ECOG performance status 0 to 2.
Show all 53Show fewer
- Life expectancy of at least 6 months.
- Clinically assessed as scheduled to undergo radical prostatectomy and pelvic lymph node dissection (including patients with localized disease, regional lymph node metastases, or oligometastatic prostate cancer), with no contraindications to surgery.
- Participants must meet one of the following risk categories: unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer, as defined according to the NCCN Guidelines (Version 2026, Version 5; PROS-2):
- Unfavorable intermediate-risk prostate cancer, defined as meeting any of the following criteria:
- ISUP Grade Group (GG) 3; or
- GG 2 with ≥50% of biopsy cores positive for prostate cancer; and/or
- Presence of ≥2 intermediate-risk factors, including clinical stage cT2b or cT2c and PSA 10-20 ng/mL.
- High-risk prostate cancer, defined as meeting at least one high-risk feature but not meeting criteria for very high-risk disease, including:
- Clinical stage cT3a; or
- GG 4 or 5; or
- PSA >20 ng/mL.
- Very high-risk prostate cancer, defined as meeting at least two of the following criteria:
- Clinical stage cT3b-cT4;
- GG 4 or 5;
- PSA >40 ng/mL.
- Creatinine clearance ≥50 mL/min, as calculated using the Cockcroft-Gault formula.
- Male participants must agree to use highly effective contraception for 4 weeks after administration of the investigational product and must refrain from donating sperm during this period.
- Phase II
- Participants must meet all of the following criteria to be eligible for enrollment:
- Able to provide written informed consent prior to initiation of any study-specific procedures.
- Male participants aged ≥18 years.
- Histologically confirmed prostate cancer.
- ECOG performance status of 0-2.
- Estimated life expectancy ≥6 months.
- Creatinine clearance ≥50 mL/min, as calculated using the Cockcroft-Gault formula.
- Male participants must agree to use highly effective contraception for 4 weeks after administration of the investigational product and must refrain from donating sperm during this period.
- Additional Inclusion Criteria Applicable to Cohort 1 (BCR Cohort) Only
- Any clinically significant adverse events that occurred during prior therapies (e.g., chemotherapy, radiotherapy, immunotherapy) have resolved to CTCAE Grade ≤2 (with the exception of alopecia).
- Participants have previously undergone definitive therapy.
- Participants with suspected prostate cancer recurrence based on rising PSA levels following definitive therapy, defined as follows:
- Post-radical prostatectomy: detectable or persistently rising PSA levels, with PSA ≥0.2 ng/mL, confirmed by a second measurement showing PSA ≥0.2 ng/mL (per American Urological Association [AUA] recommendations); or
- Post-radiotherapy, cryotherapy, or brachytherapy: PSA increase of ≥2 ng/mL above the nadir, in accordance with the American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition.
- Additional Inclusion Criteria Applicable to Cohort 2 (pre-RP Cohort) Only
- Clinically assessed as scheduled to undergo radical prostatectomy and pelvic lymph node dissection (including patients with localized disease, regional lymph node metastases, or oligometastatic prostate cancer), with no contraindications to surgery.
- Participants must meet one of the following risk categories: unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer, as defined according to the NCCN Guidelines (Version 2026, Version 5; PROS-2):
- Unfavorable intermediate-risk prostate cancer, defined as meeting any of the following criteria:
- ISUP Grade Group (GG) 3; or
- GG 2 with ≥50% of biopsy cores positive for prostate cancer; and/or
- Presence of ≥2 intermediate-risk factors, including clinical stage cT2b or cT2c and PSA 10-20 ng/mL.
- High-risk prostate cancer, defined as meeting at least one high-risk feature but not meeting criteria for very high-risk disease, including:
- Clinical stage cT3a; or
- GG 4 or 5; or
- PSA >20 ng/mL.
- Very high-risk prostate cancer, defined as meeting at least two of the following criteria:
- Clinical stage cT3b-cT4;
- GG 4 or 5;
- PSA >40 ng/mL.
Who cannot join
- Phase I
- Participants meeting any of the following criteria will be excluded from the study:
- Known or suspected hypersensitivity to the active component(s) of [⁶⁴Cu]Cu-RAX301 Injection or any of its excipients.
- Inability to complete [⁶⁴Cu]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
- Participation in another interventional clinical trial prior to signing the informed consent form, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
- Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.
Show all 22Show fewer
- Prior treatment with androgen deprivation therapy (ADT) or any other neoadjuvant therapy.
- Receipt of high-energy gamma radiation (>300 keV) prior to dosing, within 5 half-lives of the investigational product.
- QTcF interval ≥470 msec on 12-lead ECG (corrected using Fridericia's formula).
- Any medical condition that, in the investigator's judgment, may compromise participant safety, protocol compliance, or interpretation of study results.
- Phase II
- Known or suspected hypersensitivity to the active component(s) of [⁶⁴Cu]Cu-RAX301 Injection or any of its excipients.
- Inability to complete [⁶⁴Cu]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
- Participation in another interventional clinical trial prior to signing informed consent, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
- Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.
- Receipt of high-energy gamma radiation (>300 keV) prior to dosing, within 5 half-lives of the investigational product.
- QTcF interval ≥470 msec on 12-lead ECG (corrected using Fridericia's formula).
- Any medical condition that, in the investigator's judgment, may compromise participant safety, protocol compliance, or interpretation of study results.
- Additional Exclusion Criteria Applicable to Cohort 1 (BCR Cohort) Only
- Receipt of systemic anticancer therapy for prostate cancer within 90 days prior to dosing (including but not limited to androgen deprivation therapy, antiandrogens, gonadotropin-releasing hormone agonists or antagonists, bone-targeted radiopharmaceuticals, or radiotherapy).
- Exclusion Criteria - Applicable to Phase II Cohort 2 (pre-RP Cohort) Only
- Prior treatment with androgen deprivation therapy (ADT) or any other neoadjuvant therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Min Hong, PhD contact
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 Injection in Patients With Prostate Cancer
This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and preliminary diagnostic performance of [⁶⁴Cu]Cu-RAX301 Injection in patients with prostate cancer.
Phase I will evaluate two administered activity levels of [⁶⁴Cu]Cu-RAX301 Injection in participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection (pre-RP population) and will support selection of the administered activity for Phase II.
Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected recurrence or biochemical recurrence of prostate cancer and participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection.
Read the detailed description
COPRA424 is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study of [⁶⁴Cu]Cu-RAX301 Injection, a prostate-specific membrane antigen (PSMA)-targeted PET radiodiagnostic agent, in patients with prostate cancer.
Approximately 52 participants are planned for enrollment: 12 participants in Phase I and approximately 40 participants in Phase II.
In Phase I, 12 participants with prostate cancer who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection will be assigned by administered activity to receive a single intravenous administration of either 5 ± 10% mCi or 8 ± 10% mCi [⁶⁴Cu]Cu-RAX301 Injection, with 6 participants in each activity group. Participants will undergo serial PET/CT imaging for biodistribution and radiation dosimetry assessments and blood and urine sampling for pharmacokinetic, radioactivity excretion, and metabolite analyses. Imaging characteristics will also be evaluated at 4 ± 1 hours and 24 ± 2 hours after administration. Safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics, imaging characteristics, and preliminary diagnostic performance will be evaluated to support selection of the administered activity for Phase II.
Phase II will use the administered activity selected based on Phase I and will include two independent expansion cohorts. Cohort 1 will enroll approximately 20 participants with suspected recurrence or biochemical recurrence of prostate cancer. Cohort 2 will enroll approximately 20 participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection. Participants will receive a single intravenous administration of [⁶⁴Cu]Cu-RAX301 Injection and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration.
Phase II will primarily evaluate the preliminary diagnostic performance, biodistribution characteristics, and safety of [⁶⁴Cu]Cu-RAX301 PET/CT in the two target populations. For the pre-RP population, postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection will serve as an important component of the standard of truth for evaluation of diagnostic performance. For the biochemical recurrence population, diagnostic performance will be evaluated using a prespecified composite reference standard.
Study imaging findings are exploratory and should not serve as the sole basis for major clinical management decisions unless confirmed by non-investigational methods.
- Conditions
- Prostate Cancer
- Being tested
- [⁶⁴Cu]Cu-RAX301 Injection
- Keywords
- pre-RP, BCR, PSMA PET, [⁶⁴Cu]Cu-RAX301, Prostate Cancer, RAX301, Biochemical Recurrence, Pre-Radical Prostatectomy, Copper-64, Radiopharmaceutical Imaging, PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[⁶⁴Cu]Cu-RAX301 InjectionDrug
[⁶⁴Cu]Cu-RAX301 Injection is a PSMA-targeted PET radiodiagnostic agent administered as a single intravenous injection. In Phase I, participants will receive an administered activity of either 5 ± 10% mCi or 8 ± 10% mCi. Serial PET/CT imaging will be performed at approximately 1, 4, 8, 24, and 48 hours after administration for biodistribution and radiation dosimetry assessments, with imaging characteristics evaluated at 4 ± 1 hours and 24 ± 2 hours. In Phase II, participants will receive the administered activity selected based on Phase I and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration.
| Study group | Role | What they receive |
|---|---|---|
| [⁶⁴Cu]Cu-RAX301 PET/CT | Experimental | Participants will receive a single intravenous administration of [⁶⁴Cu]Cu-RAX301 Injection followed by protocol-specified PET/CT imaging. In Phase I, pre-RP participants will receive either 5 ± 10% mCi or 8 ± 10% mCi [⁶⁴Cu]Cu-RAX301 Injection, with 6 participants in each administered activity group. The Phase I results will support selection of the administered activity for Phase II. In Phase II, participants in the BCR and pre-RP expansion cohorts will receive the selected administered activity and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration. Receives: Drug: [⁶⁴Cu]Cu-RAX301 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [⁶⁴Cu]Cu-RAX301 Injection, together with clinically relevant changes from baseline in physical examinations, vital signs, clinical laboratory assessments, and 12-lead electrocardiograms.
Measured: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days
Participant-Level Correct Detection Rate of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort
Participant-level correct detection rate (CDR) of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, based on the prespecified composite standard of truth. CDR is defined as the proportion of scanned participants with at least one true-positive region among participants with at least one evaluable reference-standard assessment.
Measured: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when PSA response following local radiotherapy is used for confirmation
Region-Level Positive Predictive Value of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort
Region-level positive predictive value (PPV) of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration. PPV will be determined among PET-positive regions with an evaluable standard-of-truth status.
Measured: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when applicable
Participant-Level Sensitivity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort
Participant-level sensitivity of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.
Measured: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
Participant-Level Specificity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort
Participant-level specificity of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.
Measured: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
Secondary outcomes (6)
The biodistribution and radiation dosimetry characteristics of [⁶⁴Cu]Cu-RAX301 Injection at 5 ± 10% mCi, and the pharmacokinetic (PK) characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two administered activity levels, 5 ± 10% mCi and 8 ± 10% mCi.
Measurement of quantitative biodistribution and radiation dosimetry parameters at 5 ± 10% mCi, including uptake parameters in regions of interest (e.g., SUVmax and SUVmean), %ID, residence time, organ absorbed dose, and effective dose.
Measurement of pharmacokinetic parameters in blood and plasma, including Cmax, Tmax, t½, AUC₀-t, AUC₀-∞, and CL, as well as whole blood-to-plasma ratios, circulating metabolite profiles, and urinary excretion and metabolite profiles.
Measured: Pre-dose through approximately 48 hours after administration
The imaging characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two PET/CT imaging time points, 4 ± 1 h and 24 ± 2 h after administration - Phase 1.
Measurement of PET/CT imaging characteristics at 4 ± 1 h and 24 ± 2 h after administration, including lesion uptake parameters (SUVmax and SUVmean), target-to-background ratio (TBR), and image quality assessment, including Likert image quality score and the quantitative image quality parameter of signal-to-noise ratio. Measurement of inter-reader and intra-reader agreement.
Measured: 4 ± 1 hours and 24 ± 2 hours after administration
Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase I
Exploratory participant-level and region-level diagnostic performance, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). For the pre-RP population, postsurgical histopathology from radical prostatectomy and pelvic lymph node dissection will serve as the reference standard.
Measured: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
PET/CT Uptake and Biodistribution Parameters - Phase II
SUVmax, SUVmean, and target-to-background ratio in relevant organs, tissues, and lesions following administration of [⁶⁴Cu]Cu-RAX301.
Measured: 4 ± 1 hours and 24 ± 2 hours after administration
Inter-Reader and Intra-Reader Agreement for [⁶⁴Cu]Cu-RAX301 PET/CT
Agreement in interpretation of [⁶⁴Cu]Cu-RAX301 PET/CT images between and within central independent readers, assessed using kappa statistics, as applicable.
Measured: Based on PET/CT images acquired at 4 ± 1 hours and 24 ± 2 hours after administration
Incidence and Severity of Adverse Events and Serious Adverse Events - Phase II
Incidence and severity of AEs and SAEs and clinically relevant changes from baseline in physical examination findings, vital signs, clinical laboratory assessments, and 12-lead ECGs.
Measured: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, Phase I/II exploratory diagnostic imaging study. In Phase I, participants scheduled for radical prostatectomy and pelvic lymph node dissection will receive one of two administered activity levels of \[⁶⁴Cu\]Cu-RAX301 Injection (5 ± 10% mCi or 8 ± 10% mCi) to evaluate safety, dosimetry, pharmacokinetics, imaging characteristics, and preliminary diagnostic performance and to support selection of an administered activity for Phase II. Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected or biochemical recurrence of prostate cancer and participants scheduled for radical prostatectomy and pelvic lymph node dissection.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RadAlliance Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Junkanglitai Biosciences Co. Ltd., Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Hongcheng Shi, MD PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765940
- Sponsor's protocol ID
- COPRA424
- Acronym
- COPRA424
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 Injection in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07765940
- Acronym / sponsor ID
- COPRA424 / COPRA424
- Conditions
- Prostate Cancer
- Keywords
- pre-RP, BCR, PSMA PET, [⁶⁴Cu]Cu-RAX301, Prostate Cancer, RAX301, Biochemical Recurrence, Pre-Radical Prostatectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- RadAlliance Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Junkanglitai Biosciences Co. Ltd., Shanghai Zhongshan Hospital
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 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.
This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and preliminary diagnostic performance of [⁶⁴Cu]Cu-RAX301 Injection in patients with prostate cancer.
Phase I will evaluate two administered activity levels of [⁶⁴Cu]Cu-RAX301 Injection in participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection (pre-RP population) and will support selection of the administered activity for Phase II.
Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected recurrence or biochemical recurrence of prostate cancer and participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection.
Detailed description
COPRA424 is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study of [⁶⁴Cu]Cu-RAX301 Injection, a prostate-specific membrane antigen (PSMA)-targeted PET radiodiagnostic agent, in patients with prostate cancer.
Approximately 52 participants are planned for enrollment: 12 participants in Phase I and approximately 40 participants in Phase II.
In Phase I, 12 participants with prostate cancer who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection will be assigned by administered activity to receive a single intravenous administration of either 5 ± 10% mCi or 8 ± 10% mCi [⁶⁴Cu]Cu-RAX301 Injection, with 6 participants in each activity group. Participants will undergo serial PET/CT imaging for biodistribution and radiation dosimetry assessments and blood and urine sampling for pharmacokinetic, radioactivity excretion, and metabolite analyses. Imaging characteristics will also be evaluated at 4 ± 1 hours and 24 ± 2 hours after administration. Safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics, imaging characteristics, and preliminary diagnostic performance will be evaluated to support selection of the administered activity for Phase II.
Phase II will use the administered activity selected based on Phase I and will include two independent expansion cohorts. Cohort 1 will enroll approximately 20 participants with suspected recurrence or biochemical recurrence of prostate cancer. Cohort 2 will enroll approximately 20 participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection. Participants will receive a single intravenous administration of [⁶⁴Cu]Cu-RAX301 Injection and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration.
Phase II will primarily evaluate the preliminary diagnostic performance, biodistribution characteristics, and safety of [⁶⁴Cu]Cu-RAX301 PET/CT in the two target populations. For the pre-RP population, postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection will serve as an important component of the standard of truth for evaluation of diagnostic performance. For the biochemical recurrence population, diagnostic performance will be evaluated using a prespecified composite reference standard.
Study imaging findings are exploratory and should not serve as the sole basis for major clinical management decisions unless confirmed by non-investigational methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, Phase I/II exploratory diagnostic imaging study. In Phase I, participants scheduled for radical prostatectomy and pelvic lymph node dissection will receive one of two administered activity levels of [⁶⁴Cu]Cu-RAX301 Injection (5 ± 10% mCi or 8 ± 10% mCi) to evaluate safety, dosimetry, pharmacokinetics, imaging characteristics, and preliminary diagnostic performance and to support selection of an administered activity for Phase II. Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected or biochemical recurrence of prostate cancer and participants scheduled for radical prostatectomy and pelvic lymph node dissection.
| Arm | Type | Receives |
|---|---|---|
| [⁶⁴Cu]Cu-RAX301 PET/CT | Experimental | Drug: [⁶⁴Cu]Cu-RAX301 InjectionParticipants will receive a single intravenous administration of [⁶⁴Cu]Cu-RAX301 Injection followed by protocol-specified PET/CT imaging. In Phase I, pre-RP participants will receive either 5 ± 10% mCi or 8 ± 10% mCi [⁶⁴Cu]Cu-RAX301 Injection, with 6 participants in each administered activity group. The Phase I results will support selection of the administered activity for Phase II. In Phase II, participants in the BCR and pre-RP expansion cohorts will receive the selected administered activity and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (53 listed)
- Phase I
- Able to provide written informed consent prior to initiation of any study-specific procedures.
- Male participants aged ≥18 years.
- Histologically confirmed prostate cancer.
- ECOG performance status 0 to 2.
Key exclusion criteria (22 listed)
- Phase I
- Known or suspected hypersensitivity to the active component(s) of [⁶⁴Cu]Cu-RAX301 Injection or any of its excipients.
- Inability to complete [⁶⁴Cu]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
- Participation in another interventional clinical trial prior to signing the informed consent form, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
- Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.
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 |
|---|---|---|
| [⁶⁴Cu]Cu-RAX301 Injection[⁶⁴Cu]Cu-RAX301 Injection is a PSMA-targeted PET radiodiagnostic agent administered as a single intravenous injection. In Phase I, participants will receive an administered activity of either 5 ± 10% mCi or 8 ± 10% mCi. Serial PET/CT imaging will be performed at approximately 1, 4, 8, 24, and 48 hours after administration for biodistribution and radiation dosimetry assessments, with imaging characteristics evaluated at 4 ± 1 hours and 24 ± 2 hours. In Phase II, participants will receive the administered activity selected based on Phase I and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration. | Drug | [⁶⁴Cu]Cu-RAX301 PET/CT |
Primary outcome
The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1
Time frame: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [⁶⁴Cu]Cu-RAX301 Injection, together with clinically relevant changes from baseline in physical examinations, vital signs, clinical laboratory assessments, and 12-lead electrocardiograms.
Participant-Level Correct Detection Rate of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort
Time frame: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when PSA response following local radiotherapy is used for confirmation
Participant-level correct detection rate (CDR) of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, based on the prespecified composite standard of truth. CDR is defined as the proportion of scanned participants with at least one true-positive region among participants with at least one evaluable reference-standard assessment.
Region-Level Positive Predictive Value of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort
Time frame: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when applicable
Region-level positive predictive value (PPV) of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration. PPV will be determined among PET-positive regions with an evaluable standard-of-truth status.
Participant-Level Sensitivity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort
Time frame: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
Participant-level sensitivity of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.
Participant-Level Specificity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort
Time frame: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
Participant-level specificity of [⁶⁴Cu]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.
6 secondary outcomes
The biodistribution and radiation dosimetry characteristics of [⁶⁴Cu]Cu-RAX301 Injection at 5 ± 10% mCi, and the pharmacokinetic (PK) characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two administered activity levels, 5 ± 10% mCi and 8 ± 10% mCi.
Time frame: Pre-dose through approximately 48 hours after administration
The imaging characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two PET/CT imaging time points, 4 ± 1 h and 24 ± 2 h after administration - Phase 1.
Time frame: 4 ± 1 hours and 24 ± 2 hours after administration
Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase I
Time frame: PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration
PET/CT Uptake and Biodistribution Parameters - Phase II
Time frame: 4 ± 1 hours and 24 ± 2 hours after administration
Inter-Reader and Intra-Reader Agreement for [⁶⁴Cu]Cu-RAX301 PET/CT
Time frame: Based on PET/CT images acquired at 4 ± 1 hours and 24 ± 2 hours after administration
Incidence and Severity of Adverse Events and Serious Adverse Events - Phase II
Time frame: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Min Hong, PhD contact
Hongcheng Shi, MD PhD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [⁶⁴Cu]Cu-RAX301 Injection in people with Prostate Cancer, run by RadAlliance Therapeutics, Inc.
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 53 inclusion and 22 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Guangzhou Han, PhD, MD (7167481409, guangzhou.han@radalliancetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1 (time frame: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days). The study lists 5 primary outcomes in all. 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 14 Aug 2026.