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Metastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 2NCT05670106

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC

A Phase 2 study testing [177Lu]Lu-PSMA-617 and 68Ga-PSMA-11 in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Novartis Pharmaceuticals at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of [177Lu]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen… Read more about this study

Who is it for?
Ages 18 to 100 years, men only
What is being tested?
[177Lu]Lu-PSMA-617 and 68Ga-PSMA-11
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
17 sitesChina
Study dates
16 May 2023to 22 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained before any assessment is performed.
  • Participants must be Chinese male adults >= 18 years of age.
  • Participants must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules.
  • Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7 nmol/L).
  • Participants must have received at least one ARPI (such as enzalutamide and/orabiraterone).
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  • Participants must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
  • A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.)
  • Documented progressive mCRPC, based on at least 1 of the following criteria:
  • Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng/ml
  • Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)
  • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016)
  • Participants must have >= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =< 21 days prior to enrollment via central reading.
  • In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading
  • Participants must have adequate organ function:
  • Bone marrow reserve:
  • White blood cell (WBC) count >= 2.5 × 109/L OR absolute neutrophil count (ANC) >= 1.5 × 109/L
  • Platelets >=100 × 109/L
  • Hemoglobin >= 9 g/dL
  • Hepatic:
  • Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =< 3 × ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 3.0 × ULN OR =< 5.0 × ULN for participants with liver metastases
  • Renal:
  • eGFR >= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation
  • Albumin >3.0 g/dL.

Who cannot join

  • Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
  • Previous PSMA-targeted radioligand therapy.
  • Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies], APRI is not included) within 28 days prior to day of enrollment.
  • Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors [PARPi]) within 28 days prior to day of enrollment.
  • History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
Show all 11Show fewer
  • Transfusion for the sole purpose of making a subject eligible for study inclusion.
  • Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
  • Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids.
  • Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.
  • Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510120

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Tianjin, 300300

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

  • Novartis Investigative Site

    Xian, Shanxi, 710032

  • Novartis Investigative Site

    Xian, Shanxi, 710061

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003

  • Novartis Investigative Site

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of [177Lu]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of [68Ga]Ga-PSMA-11 were assessed.

Data from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of [177Lu]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.

Read the detailed description

This was a 2-part study:

  1. Main part: Thirty participants with at least 1 measurable lesion by PCWG3-modified RECIST v1.1 criteria were enrolled in the main part. The primary endpoint of confirmed overall response rate (ORR) was analyzed with participants in this part and was assessed via independent centralized review of radiographic images provided by the Investigator and as outlined in PCWG3-modified RECIST v1.1 criteria.
  2. Extension part: The extension part enrolled additional 30 participants with or without measurable lesions following the main part. The secondary endpoints were analyzed with all participants in both main part and extension part.

Screening and enrollment period:

Written informed consent form (ICF) was obtained prior to any screening procedures. All screening procedures described in the Assessment Schedule were completed within 28 days prior to enrollment, except for radiographic imaging assessment, which was done within 21 days prior to enrollment.

The participants were assessed for eligibility and underwent a mandatory [68Ga]Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan to evaluate Prostate-specific Membrane Antigen (PSMA) positivity for eligibility as assessed by central readers. Only participants with PSMA positive cancer and confirmed eligibility criteria were enrolled.

Following completion of all required screening procedures and verifying participant eligibility, the participant was enrolled. [177Lu]Lu-PSMA-617 was ordered in parallel with interactive response technology (IRT) enrollment registration to allow at least 2 weeks to order and deliver [177Lu]Lu-PSMA-617.

Treatment period:

In principle, all participants should begin [177Lu]Lu-PSMA-617 dosing within 14 days after enrollment registration. However, Cycle 1 Day 1 (C1D1) could be delayed by up to an additional 3 days only for unexpected scheduling delays. Participants received 7.4 Gigabecquerel (GBq) (200 Millicuries (mCi)) +/- 10% [177Lu]Lu-PSMA-617 once every 6 weeks for a planned 6 cycles. BSC/BSoC coud be used, including available care for the eligible participants according to best institutional practice. ARPIs (e.,g., abiraterone, etc.) were allowed. BSC/BSoC for each participant was selected at the discretion of the Investigator prior to [177Lu]Lu-PSMA-617 administration, and could be modified over time as needed. BSC/BSoC was administered per the physician's orders according to clinical best practice.

Radiographic imaging (CT with contrast/Magnetic Resonance Imaging (MRI) and bone scan) was done at every 8 weeks (± 4 days) after first dose of [177Lu]Lu-PSMA-617 for the first 24 weeks (independent of dose delays), then every 12 weeks (± 4 days) thereafter and at End of Treatment (EOT) Visit (if not done within 28 days of EOT) until radiographic disease progression confirmed by central reader, death, withdrawal of consent, loss to follow-up, or subject/guardian's decision.

After the last day of study treatment period of [177Lu]Lu-PSMA-617 (i.e. after completion of 6 cycles of treatment OR treatment discontinuation for any reason) [e.g. upon radiographic progression as confirmed by blinded independent centralized review]), the participants have to have an EOT visit performed ≤ 7 days and enter into the Post-treatment Follow-up period.

If a participant withdrew consent for the treatment period of the study, an EOT is supposed to be done and the participant would enter into the Post-treatment Follow-up unless he specifically withdrew consent for post-treatment follow-up.

Post-treatment Follow-up period:

  1. 30-day Safety Follow-up. All treated participants are to have a safety follow-up conducted approximately 30 days after EOT visit.
  2. Long term Follow-up. The long-term follow-up would start after the 30-day Safety follow-up and would last until study completion. If a participant in the long-term follow-up period discontinued treatment for reasons other than BICR-determined radiographic progression, his tumor assessments were required to be performed every 8 weeks after first dose of study treatment for the first 24 weeks (week 9, 17, 25) and then every 12 weeks (week 37, 49, etc) until confirmation of radiographic progression by BICR. The long-term follow-up period also includes the collection of survival and treatment updates, patient reported outcomes (PROs), serious adverse events (suspected to be related to study treatment), as well as blood sampling for hematology, chemistry testing, coagulation, and PSA. The visits are supposed to be carried out every 12 weeks (± 4 weeks) until death, lost to follow-up, withdrawal of consent, opposition to use data/biological samples or study completion, whichever occurs first. This follow-up allows the data collection on medically significant long-term toxicities, such as long-term radiotoxicity.

If the participant withdrew consent for the collection of blood samples, PROs, and imaging assessments during the long-term follow-up, the information on survival, serious adverse events (SAEs) related to study treatment and post-treatment antineoplastic therapy are to be collected.

PK/dosimetry assessments:

Both PK and dosimetry of [68Ga]Ga-PSMA-11 was to be evaluated in at least 10 and up to 12 participants (at least 6 participants in main part). PK and dosimetry of [68Ga]Ga-PSMA-11 could be evaluated in any participant regardless of his PSMA status.

Both PK and dosimetry of [177Lu]Lu-PSMA-617 are to be evaluated in at least 10 and up to 12 participants (at least 6 participants in main part).

Participants who took part in PK and dosimetry evaluation of [177Lu]Lu-PSMA-617 were to take part in the efficacy and safety evaluation together with the other participants. The treatment and assessment procedure followed the same as above.

Being tested
[177Lu]Lu-PSMA-617, Best supportive/best standard of care (BS/BSOC), 68Ga-PSMA-11
Keywords
Chinese adult male population, therapeutic agent lutetium (177Lu) vipivotide tetraxetan, AAA617, [177Lu]Lu-PSMA-617, radiolabeled compound gallium (68Ga) gozetotide, [68Ga]Ga-PSMA-11, Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer, Overall Response Rate, ORR, Prostate-specific Membrane Antigen, PSMA, Taxane, Androgen Receptor Pathway Inhibitor, ARPI

What participants receive

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

  • [177Lu]Lu-PSMA-617Drug

    Also called AAA617

    Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

  • Best supportive/best standard of care (BS/BSOC)Other

    Best supportive/best standard of care as defined by the local investigator

  • 68Ga-PSMA-11Drug

    Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi).

Study groups in NCT05670106
Study groupRoleWhat they receive
[177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)ExperimentalPatients received the investigational product 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) could be used.
Receives: Drug: [177Lu]Lu-PSMA-617; Other: Best supportive/best standard of care (BS/BSOC); Drug: 68Ga-PSMA-11

What is being measured

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

  1. Main part: Confirmed Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)

    Confirmed Overall Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR is based on PCWG3-modified RECIST v1.1 response for patients with measurable disease at baseline.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, approx. 1 year

Secondary outcomes (20)

  1. Main & extension parts: Radiographic progression free survival (rPFS)

    rPFS is defined as the time (in months) from the date of enrollment to the date of radiographic progression as outlined in PCWG3 guideline or death due to any cause.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first.

  2. Main & extension parts: Overall survival (OS)

    Overall survival (OS) is defined as the time(in months) from the date of enrollment to the date of death due to any cause. If a participant is not known to have died, then OS will be censored at the latest date the participant was known to be alive (on or before the cut-off date).

    Measured: From date of randomization until date of death from any cause.

  3. Main & extension parts: Overall response rate (ORR)

    Overall response rate (ORR)is defined as the proportion of participants with best overall response of complete response or partial response, as per central and local review according to PCWG3 modified RECIST 1.1

    Measured: From date of randomization till radiographic progression or date of death from any cause.

  4. Main & extension parts: Disease control rate (DCR)

    Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease, or non-CR/non-PD, as per central and local review and according to PCWG3-modified RECIST v1.1.

    Measured: From date of randomization till radiographic progression or date of death from any cause.

  5. Main & extension parts: Duration of response (DOR)

    Duration of response (DOR) is defined as the time (in months) from the date of the first documented response (CR or PR) to the date of first documented progression according to PCWG3-modified RECIST v1.1 or death due to any cause, among participants with a confirmed response.

    Measured: From date of randomization until date of progression or date of death from any cause.

  6. Main & extension parts: Time to a first symptomatic skeletal event (TTSSE)

    TTSSE is defined as the time (in months) from the date of enrollment to the date of SSE or death due to any cause. The SSE date is date of the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever comes first.

    Measured: From date of randomization till date of a first SSE or date of death from any cause.

  7. Main & extension parts: PSA50 response rate

    PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of >= 50% from baseline that is confirmed by a second consecutive PSA measurement >= 4 weeks later.

    Measured: From date of randomization till end of long-term FU.

  8. Main & extension parts: Progression Free Survival (PFS)

    PFS (Radiographic/clinical/PSA progression) is defined as the time (in months) from the date of enrollment to the date of radiographic, clinical or PSA progression free survival, or death due to any cause, whichever occurs first.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever come first.

  9. Main & extension parts: European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)

    FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.

    Measured: From date of randomization till the end of long term FU

  10. Main & extension parts: Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire

    FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.

    Measured: From date of randomization till 30 day safety follow-up or at the end of long term FU for patients prematurely discontinued, assessed up to 57 months (estimated final OS analysis)

  11. Main & extension parts: Brief Pain Inventory - Short Form (BPI-SF) Questionnaire

    The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.

    Measured: From date of randomization till the end of long term FU

  12. Main & extension parts: Number of Participants with Treatment Emergent Adverse Events

    The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: From day of the first administration of study treatment to 30 days after EOT or to the last [177Lu]Lu-PSMA-617 dose date + 41 days, whichever is later.

  13. Main & extension parts: Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-PSMA-617

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [177Lu]Lu-PSMA-617 in at least 10 and up to 14 patients. AUClast will be listed and summarized using descriptive statistics.

    Measured: Cycle 1 Week 1(Day 1) and Cycle 1 Week 2(Day 8): Pre dose, 0(End of infusion), 20 & 60 mins(+/- 5 mins), 2 & 4 hours(+/-30 mins), 24 hours(+/- 2 hr), 48 hours(+/- 4 hr), 72 hours(+/- 6 hr), 168 hours(+/- 12 hr) from the end of infusion (1 cycle=42 days)

  14. Main & extension parts: Observed maximum blood concentration (Cmax) of [177Lu]Lu-PSMA-617

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [177Lu]Lu-PSMA-617 in at least 10 and up to 14 patients. Cmax will be listed and summarized using descriptive statistics.

    Measured: Cycle 1 Week 1(Day 1) and Cycle 1 Week 2(Day 8): Pre dose, 0(End of infusion), 20 & 60 mins(+/- 5 mins), 2 & 4 hours(+/-30 mins), 24 hours(+/- 2 hr), 48 hours(+/- 4 hr), 72 hours(+/- 6 hr), 168 hours(+/- 12 hr) from the end of infusion (1 cycle=42 days)

  15. Main & extension parts: Blood concentration of [177Lu]Lu-PSMA-617

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [177Lu]Lu-PSMA-617 in at least 10 and up to 14 patients. Blood concentration of [177Lu]Lu-PSMA-617 will be summarized with descriptive statistics.

    Measured: Cycle 1 Week 1(Day 1) and Cycle 1 Week 2(Day 8): Pre dose, 0(End of infusion), 20 & 60 mins(+/- 5 mins), 2 & 4 hours(+/-30 mins), 24 hours(+/- 2 hr), 48 hours(+/- 4 hr), 72 hours(+/- 6 hr), 168 hours(+/- 12 hr) from the end of infusion (1 cycle=42 days)

  16. Main & extension parts: Organ absorbed dose of [177Lu]Lu-PSMA-617

    The quantity of ionizing radiation absorbed by organs and tissues will be summarized with descriptive statistics.

    Measured: Cycle 1 Week 1(Day 1) and Cycle 1 Week 2(Day 8): 1~2 & 4 hours, 18~26 hours, 48 hours(+/- 12 hr), 168 hours(+/- 12 hr) from the end of infusion (1 cycle=42 days)

  17. Main & extension parts: Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [68Ga]Ga-PSMA-11

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [68Ga]Ga-PSMA-11 in at least 10 and up to 14 patients. AUClast will be listed and summarized using descriptive statistics.

    Measured: Screening (Day -42 to Day -14) : 5 mins (+/- 3 mins), 15 & 30 & 45 mins (+/- 5 mins), 85 mins (+/- 10 mins), 175 & 245 mins (+/- 30 mins) from the end of infusion

  18. Main & extension parts: Observed maximum blood concentration (Cmax) of [68Ga]Ga-PSMA-11

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [68Ga]Ga-PSMA-11 in at least 10 and up to 14 patients. Cmax will be listed and summarized using descriptive statistics.

    Measured: Screening (Day -42 to Day -14) : 5 mins (+/- 3 mins), 15 & 30 & 45 mins (+/- 5 mins), 85 mins (+/- 10 mins), 175 & 245 mins (+/- 30 mins) from the end of infusion

  19. Main & extension parts: Blood concentration of [68Ga]Ga-PSMA-11

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of [68Ga]Ga-PSMA-11 in at least 10 and up to 14 patients. Blood concentration of [68Ga]Ga-PSMA-11 will be summarized with descriptive statistics.

    Measured: Screening (Day -42 to Day -14) : 5 mins (+/- 3 mins), 15 & 30 & 45 mins (+/- 5 mins), 85 mins (+/- 10 mins), 175 & 245 mins (+/- 30 mins) from the end of infusion

  20. Main & extension parts: Organ absorbed dose of [68Ga]Ga-PSMA-11

    The quantity of ionizing radiation absorbed by organs and tissues will be summarized with descriptive statistics.

    Measured: Screening (Day -42 to Day -14): 30 mins (+/- 5 mins), 60 mins (+/- 10 mins), 120 mins (+/- 20 mins) and 255 mins (+/- 30 mins) from the end of infusion

Timeline

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

  1. First posted4 Jan 2023
  2. Study start16 May 2023
  3. Primary completion17 May 2024
  4. Study completion22 Apr 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670106
Sponsor's protocol ID
CAAA617A12201
Status last verified
Sep 2026
First submitted
7 Nov 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com

Publications

  • Shi H, Guo J, Fan W, Li Y, Huang R, Dong Q, Yang Z, Yang Y, Wang X, Gu D, Huo L, Ji Z, Wang F, Xu D, Jiang Z, Li H, Li J, Li R, Qi L, Wang J, Ye D. A phase II study evaluating pharmacokinetics and dosimetry of 177Lu-PSMA-617 radioligand therapy in Chinese participants with progressive metastatic castration-resistant prostate cancer. EJNMMI Res. 2026 Mar 1;16(1):55. doi: 10.1186/s13550-026-01401-3.

    PubMed 41764712

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [177Lu]Lu-PSMA-617 and 68Ga-PSMA-11 in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Novartis Pharmaceuticals at 17 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 25 inclusion and 11 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main part: Confirmed Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) (time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, approx. 1 year). 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 NCT05670106, which also lists 1 linked publication.

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 15 Sep 2026.

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