Prostate Cancer MetastaticPROLUTNCT06461689
Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer
An observational study of Prostate Cancer Metastatic, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- 177Lu-PSMA-617
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Dec 2024to 28 Feb 2025
- 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: All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.
Who may be able to join
- patient who received a dose of 177lu-PSMA
- patient who had imaging by 68Ga-PSMA
- patient treated in Nancy hospital for its cancer prostate
Who cannot join
- no social security
- no acceptation to participating in retrospective study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617
To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.
Read the detailed description
Since few years, therapy by 177Lu-PSMA in nancy hospital began. A lot's of datas were collected. Prostate cancer is the number one killer in france and this is very important to find a diagnostic tool.
The hypothesis of this study is to demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- 177Lu-PSMA-617
- Keywords
- prostate cancer, theragnostic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-PSMA-617Drug
All patients treated with 177Lu-PSMA had a post-therapy 68Ga-PSMA PET scan and a post-therapy 177Lu-PSMA-617 SPECT/CT scan. These scans are available in the CHRU PACS, and patients are informed that their data may be used for research purposes, via posters in the nuclear medicine department or via the welcome booklet,
| Study group | Role | What they receive |
|---|---|---|
| patient treated as part of mCPRC | All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT. Receives: Drug: 177Lu-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of TMTV (total metabolic tumor volume)
Measurement of TMTV (total metabolic tumor volume) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
Measured: 12 months
Measurement of TLA (total lesion activity)
Measurement of TLA (total lesion activity) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start31 Dec 2024
- Primary completion1 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer MetastaticStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOURSIER Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461689
- Sponsor's protocol ID
- 2024PI106
- Acronym
- PROLUT
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kunsch J, Zaragori T, Olivier P, Claudin M, Marie PY, Raymond P, Heyer S, Verger A, Imbert L, Boursier C. Prognostic Value of Comprehensive Analysis of Metastatic Prostate Tumor Changes from First to Last [177Lu]Lu-PSMA Therapy Injections Through Serial High-Speed Whole-Body 360 degrees Cadmium-Zinc-Telluride SPECT. J Nucl Med. 2025 Nov 3;66(11):1695-1702. doi: 10.2967/jnumed.125.270358.
PubMed 40935614
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617
- ClinicalTrials.gov ID
- NCT06461689
- Acronym / sponsor ID
- PROLUT / 2024PI106
- Conditions
- Prostate Cancer Metastatic
- Keywords
- prostate cancer, theragnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 17 Jun 2024 (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.
To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.
Detailed description
Since few years, therapy by 177Lu-PSMA in nancy hospital began. A lot's of datas were collected. Prostate cancer is the number one killer in france and this is very important to find a diagnostic tool.
The hypothesis of this study is to demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient treated as part of mCPRC | – | Drug: 177Lu-PSMA-617All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.
Key inclusion criteria (3 listed)
- patient who received a dose of 177lu-PSMA
- patient who had imaging by 68Ga-PSMA
- patient treated in Nancy hospital for its cancer prostate
Key exclusion criteria (2 listed)
- no social security
- no acceptation to participating in retrospective study
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 |
|---|---|---|
| 177Lu-PSMA-617All patients treated with 177Lu-PSMA had a post-therapy 68Ga-PSMA PET scan and a post-therapy 177Lu-PSMA-617 SPECT/CT scan. These scans are available in the CHRU PACS, and patients are informed that their data may be used for research purposes, via posters in the nuclear medicine department or via the welcome booklet, | Drug | patient treated as part of mCPRC |
Primary outcome
Measurement of TMTV (total metabolic tumor volume)
Time frame: 12 months
Measurement of TMTV (total metabolic tumor volume) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
Measurement of TLA (total lesion activity)
Time frame: 12 months
Measurement of TLA (total lesion activity) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
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 25 Jun 2026.
- Results publication: PubMed 40935614Kunsch J, Zaragori T, Olivier P, Claudin M, Marie PY, Raymond P, Heyer S, Verger A, Imbert L, Boursier C. Prognostic Value of Comprehensive Analysis of Metastatic Prostate Tumor Changes from First to Last [177Lu]Lu-PSMA Therapy Injections Through Serial High-Speed Whole-Body 360 degrees Cadmium-Zinc-Telluride SPECT. J Nucl Med. 2025 Nov 3;66(11):1695-1702. doi: 10.2967/jnumed.125.270358.
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RecruitingPhase 2
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Active, not recruitingPhase 2
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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 Prostate Cancer Metastatic, 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 3 inclusion and 2 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 25 Jun 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?
Measurement of TMTV (total metabolic tumor volume) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461689, 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 25 Jun 2026.