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Prostate NeoplasmPhase 1/2NCT03828838

Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

A Phase 1/2 study testing Lu-177 PSMA-617 in people with Prostate Neoplasm, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasm
What is being tested?
Lu-177 PSMA-617
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNetherlands
Study dates
1 Jul 2018to 1 Nov 2019
Phase
Phase 1/2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological proven adenocarcinoma of the prostate
  • Prior local therapy for prostate cancer
  • Biochemical recurrence or clinical progression after local therapy (PSA > 0.2 µg/l),
  • PSA-DT < 6 months
  • Gallium-68 (68Ga)-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 10 metastases (at least 1 lesion with a lesion size of ≥1 cm to enable adequate dosimetry studies)
  • Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions)
Show all 15Show fewer
  • No prior hormonal therapy or chemotherapy; testosteron > 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 3 months
  • No visceral metastases
  • Laboratory values:
  • White blood cells > 3.5 x 109/l
  • Platelet count > 150 x 109/l
  • Hemoglobin > 6 mmol/l
  • Alanine transaminase, aspartate aminotransferase < 3 x upper limit of normal
  • Modification of Diet in Renal Disease Study glomerular filtration rate ≥ 60 ml/min
  • Signed informed consent

Who cannot join

  • No detectable lesions on the Ga-68 PSMA PET/CT with an uptake level below the liver uptake.
  • A known subtype other than prostate adenocarcinoma
  • Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
  • Prior hip replacement surgery potentially influencing performance of PSMA PET/CT and nano Magnet Resonance Tomography (nMRI)
  • Contra-indication for MRI imaging (claustrophobia, implanted electric and electronic devices (heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators), intracranial metal clips, metallic bodies in the eye)
  • Contra-indication for Buscopan (allergy to hyoscine or any other ingredients of this medication, allergy to to other atropines (e.g. atropine, scopolamine), myasthenia gravis, enlarged colon, glaucoma or obstructive prostatic hypertrophy)
  • Additional contra-indications for the intravenous injection form of Buscopan (taking blood thinning medication (e.g. warfarin, heparin), narrowing of the gastrointestinal tract, fast heartbeat, angina or heart failure)
  • Contra-indication to glucagon (pheochromocytoma)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radiology and Nuclear Medicine

    Nijmegen, Gelderland, 6525GA

Other trials in Netherlands

About this study

Official title: Pilot Study: Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer (mCRPC) patients. However, there are no prospective studies published so far using this treatment approach in hormone sensitive setting. In this pilot study patients with hormone sensitive prostate cancer who did not undergo hormonal treatment will be treated with Lu-177 PSMA-617.

Read the detailed description

Radioligand therapy (RLT) is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied in nuclear medicine departments world-wide to treat metastatic castrate resistant prostate cancer (mCRPC) patients.

A large retrospective study reported an overall biochemical response rate of 45% following multiple 177Lu-PSMA RLT cycles in mCRPC patients, while 40% of patients already responded after a single cycle. RLT with PSMA ligand PSMA-617 was generally well tolerated and 12% of the patients suffered grade 3 to 4 hematological toxicity. In addition, mild and often transient xerostomia occurred in 8%. These results were confirmed in a smaller scale prospective study published recently.

Although these results are very promising, it is noteworthy that all currently Lu-177-PSMA-617 RLT only has been evaluated in end stage prostate cancer patients to date. In theory, RLT could be more effective in low volume disease because of the very high tumor uptake of radioligands in small lesions. There are no published data so far evaluating the therapeutic effect of Lu-177-PSMA-617 RLT in an earlier stage of the disease. Because of the difference in tumor load between mCRPC patients and patients with low volume metastatic disease, dosimetry and toxicity in these patients need evaluation. Here a clinical trial to investigate the efficacy of Lu-177-PSMA-617 RLT in patients with low volume metastatic prostate cancer, prior to the hormone insensitive state is proposed.

Objective: The aim of this study is to evaluate the dosimetry and toxicity of Lu-177-PSMA-617 RLT, in patients with low volume, hormone sensitive metastatic prostate cancer under treatment condition. Ultimately, the goal of this study is to stabilize previously progressive disease in these patients and to improve the quality of life by postponing the need for androgen deprivation therapy (ADT).

Being tested
Lu-177 PSMA-617
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Lu-177 PSMA-617Drug

    Also called Lutetium-177 Prostate Specific Membrane Antigen

    Two cycles of Lu-177 PSMA (3GBq and 3-6 GBq)

Study groups in NCT03828838
Study groupRoleWhat they receive
Lu-177 PSMA-617ExperimentalTwo cycles with 3 and 3-6 GBq Lu-177 PSMA-617 (including 3D-dosimetry)
Receives: Drug: Lu-177 PSMA-617

What is being measured

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

  1. Doses delivered to the tumors

    Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to the tumors

    Measured: For cycle 1 (duration of one cycle is 56 days)

  2. Doses delivered to the tumors

    Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to the tumors

    Measured: For cycle 2 (duration of one cycle is 56 days)

  3. Doses delivered to organs at risk

    Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to all organs at risk

    Measured: For cycle 1 (duration of one cycle is 56 days)

  4. Doses delivered to organs at risk

    Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to all organs at risk

    Measured: For cycle 2 (duration of one cycle is 56 days)

Secondary outcomes (4)

  1. PSA progression free survival

    PSA progression free survival, defined as the time from baseline to PSA progression, assessed using PCWG3 criteria on blood test results.

    Measured: Baseline, at the end of cycle 1 and 2 (each cycle is 28 days) and 3 and 6 months after last cycle

  2. Uptake on prostate specific membrane antigen (PSMA) positron emission tomography (PET)

    Comparing the changes on baseline PSMA PET and after each cycle (defined according to EORTC PET response criteria)

    Measured: Baseline, at the end of cycle 1 and 2 (each cycle is 28 days) and 3 and 6 months after last cycle

  3. Radiographic progression free survival

    Radiographic progression free survival - defined as the time from baseline to radiographic progression (assessed using Prostate Cancer Working Group 3 (PCWG3) criteria for bone lesions and RECIST 1.1 for soft tissue lesions)

    Measured: Baseline, at the end of cycle 1 and 2 (each cycle is 28 days) and 3 and 6 months after last cycle

  4. Health-related quality of life

    Health-related quality of life, assessed using a composite of the European Organisation of Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ C-30)

    Measured: Baseline, at the end of cycle 1 and 2 (each cycle is 28 days) and 3 and 6 months after last cycle

Timeline

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

  1. First posted4 Feb 2019
  2. Study start1 Jul 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03828838
Sponsor's protocol ID
NL62774.09L.r7
Status last verified
Jan 2019
First submitted
9 Jan 2019
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peters SMB, Mink MCT, Prive BM, de Bakker M, de Lange F, Muselaers CHJ, Mehra N, Witjes JA, Gotthardt M, Nagarajah J, Konijnenberg MW. Optimization of the radiation dosimetry protocol in Lutetium-177-PSMA therapy: toward clinical implementation. EJNMMI Res. 2023 Jan 24;13(1):6. doi: 10.1186/s13550-023-00952-z.

    PubMed 36692682

  • Prive BM, Peters SMB, Muselaers CHJ, van Oort IM, Janssen MJR, Sedelaar JPM, Konijnenberg MW, Zamecnik P, Uijen MJM, Schilham MGM, Eek A, Scheenen TWJ, Verzijlbergen JF, Gerritsen WR, Mehra N, Kerkmeijer LGW, Smeenk RJ, Somford DM, van Basten JA, Heskamp S, Barentsz JO, Gotthardt M, Witjes JA, Nagarajah J. Lutetium-177-PSMA-617 in Low-Volume Hormone-Sensitive Metastatic Prostate Cancer: A Prospective Pilot Study. Clin Cancer Res. 2021 Jul 1;27(13):3595-3601. doi: 10.1158/1078-0432.CCR-20-4298. Epub 2021 Apr 21.

    PubMed 33883176

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lu-177 PSMA-617 in people with Prostate Neoplasm, run by Radboud University Medical Center at 1 site in Netherlands.

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 15 inclusion and 8 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 14 Nov 2019. 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 Netherlands. 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 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?

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?

Doses delivered to the tumors (time frame: For cycle 1 (duration of one cycle is 56 days)). The study lists 4 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 NCT03828838, which also lists 2 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 14 Nov 2019.

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