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Prostate Cancer Metastatic Disease68Ga-PSMANCT06828263

Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer

An observational study of Prostate Cancer Metastatic Disease, run by University Hospital, Grenoble at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. [177Lu]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic Disease
How many people
130 participants
Where
1 siteFrance
Study dates
1 Aug 2023to Dec 2043
How long will I take part?
12 Months
Phase
Observational
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

Study population: Patients from the investigator's department only

Who may be able to join

  • Adult aged 18 or older with proven adenocarcinoma of the prostate
  • Diagnosis of progressive metastatic castration-resistant prostate cancer.
  • Progression or intolerance on a novel anti-androgen therapy (i.e. abiraterone, enzalutamide, apalutamide or darolutamide)
  • Prior therapy with at least one taxane-based chemotherapy during the course of prostate cancer or the patient is symptomatic and assessed as unfit for chemotherapy.
  • ECOG Performance status 0 to 2

Who cannot join

  • Patient opposed to the use of his data for clinical research.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Loïc DJAÏLEB, PU-PH contact

04 76 76 54 55 ext. +33

ldjaileb@chu-grenoble.fr

Marine FAURE contact

04 76 76 68 72 ext. +33

MFaure6@chu-grenoble.fr

France1 site, 1 recruiting

  • CHU Grenoble Alpes

    Grenoble, 38053

    Recruiting

Other trials in France

About this study

Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. [177Lu]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Food and Drug administration (FDA) in patients with late-stage, PSMA positive metastatic castration-resistant prostate cancer (mCRPC) based on the results from the phase 3 VISION trial [1].

Early identification of tumor progression may reduce unnecessary therapy cycles and their associated risk of adverse events as well as reducing costs and improving patient care by initiating an earlier change in treatment towards a possibly more efficacious therapy.

Read more

Response Evaluation Criteria In PSMA-imaging (RECIP) version 1.0 is an evidence-based framework to evaluate therapeutic efficacy in metastatic prostate cancer using PSMA-imaging[2,3]. Interim PSMA-PET/CT by RECIP 1.0 criteria performed at 10 weeks after two cycles of PSMA theranostics ([177Lu]Lu-PSMA- 617 or [177Lu]Lu-PSMA-I\&T) is prognostic for overall survival[2]. RECIP 1.0 criteria were validated based on overall survival outcome for measuring response in metastatic prostate cancer during androgen receptor-signaling inhibitors[4], as well as in early-stage prostate cancer in patients with biochemical recurrence after initial therapy[5].

Lutetium-177 is a beta therapy that also emits 11% gamma rays, which can be utilised to derive whole-body tomographic images similar to PSMA-PET/CT. Serial Lutetium-177 PSMA-targeted single photon emission tomography/computed tomography [177Lu]Lu-PSMA-SPECT/CT henceforth referred to as LuPSMASPECT/ CT has potential as an imaging response biomarker for 177Lu-PSMA therapy. This principle enables image quantitation and evaluation after every treatment dose. SPECT/CT post [177Lu]Lu-PSMA administration represents a potentially cost-effective alternative to interim PSMA-PET/CT.

Preliminary results have shown a good correlation between changes in LuPSMASPECT/ CT during PSMA theranostics and clinical outcome. LuPSMA-SPECT/CT can provide effective response information as early as 6 weeks after initiation of [177Lu]Lu-PSMA-I\&T, i.e. any increase in total tumor volume on SPECT/CT imaging was associated with shorter PSA-PFS (median: 3.7 vs 6.7 months; HR, 2.5; 95% CI 1.5-4.2; p<0.001)[6]. Changes in total tumor volume on 12-week LuPSMASPECT/ CT were also found to be correlated with progression-free survival after [177Lu]Lu-PSMA-I\&T[7].

The growing evidence suggesting that LuPSMA-SPECT/CT is a new, early surrogate marker for assessing response to treatment has several potential upsides, including the potential replacement of interim PSMA-PET/CT, therefore costsaving, radiation exposure-saving, and SPECT/CT imaging being more convenient and widely available.

Given that data regarding SPECT/CT-based treatment response monitoring during PSMA theranostics are limited, this study aims to prospectively investigate the role of LuPSMA-SPECT/CT imaging for response evaluation during treatment with [177Lu]Lu-PSMA in mCRPC patients.

Keywords
Prostate cancer metastatic disease, [177Lu]Lu-PSMA, metastatic castration-resistant prostate cancer, mCRPC, LuPSMA-SPECT/CT imaging

What is being measured

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

  1. Confirm prospectively the prognostic value of post-therapy SPECT/CT imaging for response evaluation during [177Lu]Lu- PSMA

    Associations between response on 177Lu-PSMA-SPECT with OS, defined as the associations between best overall response achieved on LuPSMA-SPECT/CT at any time during treatment with overall survival. The associations will be considered positive if difference in OS between PD vs nPD is statistically significant (p<0.05) as per Kaplan-Meier analysis (log-rank test).

    Measured: From treatment initiation to at least 12 months after treatment initiation

Secondary outcomes (6)

  1. Validate prognostic value of interim PSMA-PET/CT performed at 10 weeks after initiation of [177Lu]Lu-PSMA

    Associations between response on 10-week PSMA-PET/CT with OS. The associations will be considered positive if difference in OS between PD vs nPD or PD vs SD vs PR according to RECIP 1.0 is statistically significant (p<0.05) as per Kaplan-Meier analysis (log-rank test).

    Measured: From treatment initiation to at least 12 months after treatment initiation

  2. To compare cost-effectiveness of SPECT/CT versus PET/CT treatment response strategy

    Determine clinical significance of performing interim PSMA-PET/CT versus SPECT/CT for treatment response evaluation during [177Lu]Lu- PSMA. Percentage of participants with ≥1 new lesion detected on interim PSMA-PET that is not detected on LuPSMA-SPECT imaging performed at 6 weeks and/or 12 weeks. The interim PSMA-PET will be considered of clinical value if patients with ≥1 new lesion detected only on interim PSMAPET have statistically significant (p<0.05) shorter PFS and/or OS compared to patients without new lesions detected on PSMA-PET and/or LuPSMASPECT, as per Kaplan-Meier analysis (log-rank test).

    Measured: From treatment initiation to at least 12 months after treatment initiation

  3. Investigate added value of interim [18F]FDG PET to PSMA-PET/CT for response evaluation during [177Lu]Lu-PSMA

    Determine the added value of interim [18F]FDG-PET to PSMA-PET/CT for response evaluation during [177Lu]Lu-PSMA. Presence of new lesion, volume and tumor uptake changing on [18F]FDG-PET performed at 10 weeks. The interim FDG-PET will be considered of clinical value if patients with progression on FDG-PET have statistically significant (p<0.05) shorter PFS and OS compared to patients without new lesions detected on PSMA-PET and/or LuPSMA-SPECT and/or CT images, as per Kaplan-Meier analysis (log-rank test).

    Measured: From treatment initiation to at least 12 months after treatment initiation

  4. Determine clinical impact of performing interim PSMA-PET/CT versus LuPSMA-SPECT/CT for response evaluation during [177Lu]Lu-PSMA

    Correlations of LuPSMA-SPECT/CT progression-free survival (LuSPECTPFS) with OS. LuSPECT-PFS is defined as the time from treatment initiation to the date of progression on 177Lu-PSMA-SPECT/CT according to RECIP 1.0 criteria or death due to any cause, whichever occurs first [3].

    The correlations will be significant if the Spearman coefficient r is higher than 0.6 and p<0.01 [8].

    Measured: From treatment initiation to at least 12 months after treatment initiation

  5. Prognostic value of 177Lu-PSMA-SPECT/CT/PSMA PET derived tumor burden quantitative parameters for OS

    Prognostic value of 177Lu-PSMA-SPECT/CT/PSMA PET derived tumor burden quantitative parameters for OS. Total tumor volume, SUVmax, SUVmean and more advanced parameters obtained using artificial intelligence algorithms will be assessed. Association between algorithm predicted outcome with observed outcome will be tested

    Measured: From treatment initiation to at least 12 months after treatment initiation

  6. Inter-reader agreement

    Inter-reader agreement for response evaluation using interim LuPSMA- SPECT/CT and PSMA-PET/CT according to RECIP 1.0.

    Measured: From treatment initiation to at least 12 months after treatment initiation

Timeline

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

  1. First posted14 Feb 2025
  2. Study start1 Aug 2023
  3. Primary completionJun 2043 (estimated)
  4. Study completionDec 2043 (estimated)

Resources

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
Prospective
Enrolment
130 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828263
Sponsor's protocol ID
CEMEN 2024-06
Acronym
68Ga-PSMA
Status last verified
Dec 2025
First submitted
10 Feb 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gafita A, Djaileb L, Rauscher I, Fendler WP, Hadaschik B, Rowe SP, Herrmann K, Calais J, Rettig M, Eiber M, Weber M, Benz MR, Farolfi A. Response Evaluation Criteria in PSMA PET/CT (RECIP 1.0) in Metastatic Castration-resistant Prostate Cancer. Radiology. 2023 Jul;308(1):e222148. doi: 10.1148/radiol.222148.

    PubMed 37432081

  • Pathmanandavel S, Crumbaker M, Ho B, Yam AO, Wilson P, Niman R, Ayers M, Sharma S, Hickey A, Eu P, Stockler M, Martin AJ, Joshua AM, Nguyen A, Emmett L. Evaluation of 177Lu-PSMA-617 SPECT/CT Quantitation as a Response Biomarker Within a Prospective 177Lu-PSMA-617 and NOX66 Combination Trial (LuPIN). J Nucl Med. 2023 Feb;64(2):221-226. doi: 10.2967/jnumed.122.264398. Epub 2022 Aug 25.

    PubMed 36008120

  • John N, Pathmanandavel S, Crumbaker M, Counter W, Ho B, Yam AO, Wilson P, Niman R, Ayers M, Poole A, Hickey A, Agrawal S, Perkins G, Kallinen A, Eslick E, Stockler MR, Joshua AM, Nguyen A, Emmett L. 177Lu-PSMA SPECT Quantitation at 6 Weeks (Dose 2) Predicts Short Progression-Free Survival for Patients Undergoing 177Lu-PSMA-I&T Therapy. J Nucl Med. 2023 Mar;64(3):410-415. doi: 10.2967/jnumed.122.264677. Epub 2022 Sep 8.

    PubMed 36215568

  • Kendrick J, Francis RJ, Hassan GM, Rowshanfarzad P, Ong JS, McCarthy M, Alexander S, Ebert MA. Prognostic utility of RECIP 1.0 with manual and AI-based segmentations in biochemically recurrent prostate cancer from [68Ga]Ga-PSMA-11 PET images. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4077-4086. doi: 10.1007/s00259-023-06382-2. Epub 2023 Aug 8.

    PubMed 37550494

  • Shagera QA, Karfis I, Kristanto P, Spyridon S, Diamand R, Santapau A, Peltier A, Roumeguere T, Flamen P, Artigas C. PSMA PET/CT for Response Assessment and Overall Survival Prediction in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Androgen Receptor Pathway Inhibitors. J Nucl Med. 2023 Dec 1;64(12):1869-1875. doi: 10.2967/jnumed.123.265874.

    PubMed 37770114

  • Gafita A, Rauscher I, Weber M, Hadaschik B, Wang H, Armstrong WR, Tauber R, Grogan TR, Czernin J, Rettig MB, Herrmann K, Calais J, Weber WA, Benz MR, Fendler WP, Eiber M. Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study. J Nucl Med. 2022 Nov;63(11):1651-1658. doi: 10.2967/jnumed.121.263072. Epub 2022 Apr 14.

    PubMed 35422442

  • Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.

    PubMed 34161051

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer Metastatic Disease, run by University Hospital, Grenoble 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 5 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. 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?

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 Loïc DJAÏLEB, PU-PH (04 76 76 54 55 ext. +33, ldjaileb@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirm prospectively the prognostic value of post-therapy SPECT/CT imaging for response evaluation during [177Lu]Lu- PSMA (time frame: From treatment initiation to at least 12 months after treatment initiation). 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 NCT06828263, which also lists 7 linked publications.

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 26 Dec 2025.

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