Therapy-Associated CancerRECIPNCT07643935
Prognostic Value of 177Lutetium-PSMA Single Photon Emission Tomography and Timing of Response
An observational study of Therapy-Associated Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
177Lutetium-PSMA-617 is an established treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Early response assessment is critical for optimizing patient management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapy-Associated Cancer
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2026to 20 Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA
Who may be able to join
- Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA
Who cannot join
- Patients who refused to have their data used for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of [¹⁷⁷Lu]Lu-PSMA SPECT and Timing of RECIP Assessment in mCRPC
177Lutetium-PSMA-617 is an established treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
Read the detailed description
Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
It would indeed be very interesting to obtain a prognostic value using imaging performed after treatment, which also provides dosimetry information to organs at risk and to the tumor and/or metastases.
- Conditions
- Therapy-Associated Cancer
- Medical subject headings
- Neoplasms, Second Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Analysis of Standardized Uptake value
Measured: 7 days
To measure of total tumor activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Analysis of Total Tumor Activity
Measured: 7 days
To measure the tumor volume at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Analysis of Tumor Volume
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Aug 2026
- Primary completion1 Sep 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy-Associated CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IMBERT Laetitia, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643935
- Sponsor's protocol ID
- 2026PI123
- Acronym
- RECIP
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of [¹⁷⁷Lu]Lu-PSMA SPECT and Timing of RECIP Assessment in mCRPC
- ClinicalTrials.gov ID
- NCT07643935
- Acronym / sponsor ID
- RECIP / 2026PI123
- Conditions
- Therapy-Associated Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 12 Jun 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.
177Lutetium-PSMA-617 is an established treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
Detailed description
Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
It would indeed be very interesting to obtain a prognostic value using imaging performed after treatment, which also provides dosimetry information to organs at risk and to the tumor and/or metastases.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA
Key inclusion criteria (1 listed)
- Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA
Key exclusion criteria (1 listed)
- Patients who refused to have their data used for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Time frame: 7 days
Analysis of Standardized Uptake value
To measure of total tumor activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Time frame: 7 days
Analysis of Total Tumor Activity
To measure the tumor volume at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment
Time frame: 7 days
Analysis of Tumor Volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapy-Associated Cancer, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 1 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment (time frame: 7 days). The study lists 3 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 28 Oct 2026.