Prostatic NeoplasmNCT04774133
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
A study testing Blood sample in people with Prostatic Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Blood sample
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2019to 1 Jan 2022
- Phase
- Interventional
- 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
- Histologically documented prostatic cancer
- Indication to perform radiotherapy treatment
- Age over 18 years
- Informed consent
Who cannot join
- Hematological diseases
- Autoimmune diseases
- Previous neoplasias
- Prior chemotherapy or other therapies that may have violated the hematopoietic organs
- Patient's refusal to undergo periodic blood samples
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCSS Regina Elena
Roma, 00144
Giuseppe Sanguineti, Head Physician, giuseppe.sanguineti@ifo.gov.it
About this study
Official title: Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.
This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.
The final objective is to identify new therapeutic targets to be combined with RT.
- Conditions
- Prostatic Neoplasm
- Being tested
- Blood sample
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Pazients will undergo to blood samples at predefined times
What is being measured
The primary outcome is the main question the study is designed to answer.
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
quantitative variation
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 posted1 Mar 2021
- Study start14 Feb 2019
- Primary completion25 Feb 2021
- Study completion1 Jan 2022 (estimated)
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 Prostatic NeoplasmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Paola Nisticò, Iole Cordone, Adriana Faiella, Paola Trono, Serena Masi, Roberta Merola, Anna Antenucci, Maria Laura Foddai, Maria Consiglia Ferriero, Diana Giannarelli, Paolo Di Ridolfi
- Responsible party
- Principal investigator, Giuseppe Sanguineti, Regina Elena Cancer Institute
- Investigators
- Giuseppe Sanguineti, Principal investigator, IFO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774133
- Sponsor's protocol ID
- 1163/18
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rosado MM, Palermo B, Bottero M, Masi S, Petrella M, Campo G, Sperduti I, Balzano V, Faiella A, Capponi C, Russo C, Foddai ML, Russo A, Cordone I, Sanguineti G, Nistico P. Ultrahypofractionated radiotherapy better preserves B- and T-cell immunity than conventional fractionated radiotherapy in prostate cancer. J Transl Med. 2026 Aug 17;24(1):1387. doi: 10.1186/s12967-026-08773-z.
PubMed 42983563
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT04774133
- Acronym / sponsor ID
- 1163/18
- Conditions
- Prostatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Paola Nisticò, Iole Cordone, Adriana Faiella, Paola Trono, Serena Masi, Roberta Merola, Anna Antenucci, Maria Laura Foddai, Maria Consiglia Ferriero, Diana Giannarelli, Paolo Di Ridolfi
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 1 Mar 2021 (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.
Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.
This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.
The final objective is to identify new therapeutic targets to be combined with RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically documented prostatic cancer
- Indication to perform radiotherapy treatment
- Age over 18 years
- Informed consent
Key exclusion criteria (5 listed)
- Hematological diseases
- Autoimmune diseases
- Previous neoplasias
- Prior chemotherapy or other therapies that may have violated the hematopoietic organs
- Patient's refusal to undergo periodic blood samples
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 |
|---|---|---|
| Blood samplePazients will undergo to blood samples at predefined times | Diagnostic test | – |
Primary outcome
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
Time frame: 12 months
quantitative variation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 42983563Rosado MM, Palermo B, Bottero M, Masi S, Petrella M, Campo G, Sperduti I, Balzano V, Faiella A, Capponi C, Russo C, Foddai ML, Russo A, Cordone I, Sanguineti G, Nistico P. Ultrahypofractionated radiotherapy better preserves B- and T-cell immunity than conventional fractionated radiotherapy in prostate cancer. J Transl Med. 2026 Aug 17;24(1):1387. doi: 10.1186/s12967-026-08773-z.
- Individual participant dataSharing planned: Undecided
Related trials for Prostatic Neoplasm
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Natural History Study of Early Life Exposures in Agriculture (ELEA)
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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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.
Giuseppe Sanguineti principal investigator
IFO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Prostatic Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Sanguineti (0652666125, giuseppe.sanguineti@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg, (time frame: 12 months). 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 NCT04774133, 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 1 Mar 2021.