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CompletedNCT06179706Updated Mar 6, 2024

11C-choline PET/CT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients.

An observational study in Prostate Cancer, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
18 Years and older
Sex
Male
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Study summary

The number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy (RT). Until a few years ago, the treatment of choice for metastatic prostate cancer was androgen deprivation (TDA). This treatment was carried out as palliative care in order to postpone the progression of the disease or reduce symptoms. Patients with prostate cancer with a limited number of metastases, similarly to patients suffering from other solid tumors, can be considered as patients with disease that has limited capacity to cause further secondary effects. In this scenario, the primary treatment in patients with carcinoma localized prostate, is characterized by radical prostatectomy, followed by measurement of prostate specific antigen (PSA) during follow-up. After primary prostatectomy, PSA values > 0.2 ng/mL are indicative of disease recurrence, but it is not possible to determine whether the recurrence is local or distant. Furthermore, imaging modalities, such as bone scanning and computed tomography (CT), do not have sufficient sensitivity to detect the presence of metastatic disease in patients with low PSA levels. Positron emission tomography/CT with 11C-choline is able to detect local or distant metastases with a sensitivity and specificity greater than 85% in patients with biochemical disease recurrence. 11C-Choline PET/CT can be a valid tool both for diagnosis and for guiding radiotherapy treatments in these patients for whom it is not possible to obtain a definitive diagnosis with conventional diagnostic procedures. There are currently few studies that have described the use of 11C-choline PET/CT to guide treatment for bone metastases; the limitations of these studies concern the small number of patients and the short follow-up. The aim of this retrospective observational study was to evaluate the efficacy of 11C-choline PET/CT as a guide to the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer with a limited number of metastasis.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Probability sample

Study population

patients suffering from prostate cancer who have undergone primary curative treatment and who have presented biochemical recurrence of the disease.

Inclusion criteria

  • patients diagnosed with less than 3 bone lesions found on C11-Choline PET/CT
  • availability of clinical follow-up using serial PSA assays.

Exclusion criteria

Exclusion Criteria:

\<18 years patients

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • Diagnostic test11C-choline PET/CT

    In our study we evaluated the efficacy of high-dose RT guided by 11C-Choline PET/CT on bone metastases in prostate cancer patients with a limited number of metastases.

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What researchers measure

Primary outcomes

  1. 11C-choline PET/CT to the treatment of patients with prostate cancer with a limited number of metastasis.

    Retrospective observational study with 11C-choline PET/CT for the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer.

    Time frame: 1 year

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Study locations

1 site
  • Irccs San Raffaele
    Milano, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06179706
Lead sponsor
IRCCS San Raffaele
Responsible party
Chiti Arturo (Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele, IRCCS San Raffaele) — Principal investigator
First posted
Dec 22, 2023
Start date
Oct 27, 2015
Primary completion
Nov 25, 2015
Completion
Nov 25, 2015
Last update
Mar 6, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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