Prostate CancerNCT07134504
Primary Prostatic Lymphoma on a 66 Year-old Male in Mexico.
An observational study of Prostate Cancer, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
A 66-year-old male known case of diabetes and hypertension presented to the urology clinic with a 2-month history of lower urinary tract symptoms (LUTS), particularly poor flow, sense of incomplete bladder emptying, dysuria and hesitancy. Family history was negative for prostate or breast cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jul 2025to 1 Aug 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 66 Year old male.
Who may be able to join
- Patient with primary diffuse large B cell lymphoma
Who cannot join
- Patient with without primary diffuse large B cell lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Diffuse Large B Cell Lymphoma (DLBCL) of the Prostate a Case Report
A 66-year-old male known case of diabetes and hypertension presented to the urology clinic with a 2-month history of lower urinary tract symptoms (LUTS), particularly poor flow, sense of incomplete bladder emptying, dysuria and hesitancy. Family history was negative for prostate or breast cancer.
On examination, there were signs of anaemia or lymphadenopathy. His abdominal examination was unremarkable with no hepatosplenomegaly, and his digital rectal examination (DRE) revealed an irregular, moderately enlarged nodular prostate.
Read the detailed description
The patient underwent the following investigations in chronological order:
Laboratory investigations Haemoglobin: 134 g/L. Total leucocyte count: 8.6×109/L without any atypical cells. Platelets: 286×109/L. Prothrombin time/ International normalized ratio (PT/INR): 13/1.1. Creatinine: 1.1 mg/dL. Electrolytes: normal. Urine detailed report: normal. Urine culture and sensitivity: no bacterial growth. Prostate-specific antigen (PSA): 1.54 ng/mL. Radiological imaging Ultrasound of the kidney, ureter and bladder: normal non-hydronephrotic kidneys with 38 g prostate, with post void residual urine volume of 76 mL.
Based on suspicion of prostatic malignancy, he underwent MRI of the pelvis and lumbosacral (L/S) spine, whole body bone scan, and transrectal ultrasound (TRUS) guided 12-core needle biopsy of the prostate.
Bone scan: negative. MRI of the pelvis: 4.8×4.1×3.2 cm prostate with abnormal signal intensity area in the central zone appearing hypointense on T2-weighted image. The prostatic capsule and neurovascular bundles were intact.
Gross examination: TRUS biopsy showed 12 linear core tissues from both the right and left lobes of the prostate, with the largest measuring 1.1 cm.
Microscopic examination: sections from 4 cores out of 12 (2 each from the apical prostatic tissues of the right and left lobes) revealed prostate parenchyma infiltrated by atypical medium-sized to large-sized lymphoid cells arranged in diffuse sheets. These lymphoid cells exhibited scant to moderate amount of eosinophilic cytoplasm and nuclei with irregular contours, dispersed chromatin and occasional prominent nucleoli. The rest of the eight prostate tissue cores revealed benign prostate parenchyma showing glands lined by double-layered epithelium.
Immunohistochemical studies: tumour cells were strongly positive for leucocyte common antigen, CD20 (Pan-B marker), BCL-2 and CD10.The patient received alpha-adrenergic blocker tamsulosin with finasteride for LUTS with good response. For his radicular pain, he received diclofenac sodium and pregabalin. Following discussion in a multidisciplinary tumour board meeting, he received six cycles of R-CHOP (Rrituximab, Cyclophosphamide, Doxorubicin hydrochloride, Vincristine sulfate, and Prednisone) regimen at an outside cancer treatment facility.
- Conditions
- Prostate Cancer
- Keywords
- lymphoma, diffuse large B cell, urinary tract symptoms
- Medical subject headings
- Prostatic Neoplasms, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer specific survival
cancer specific survival with R-CHOP
Measured: through the end of 6 cycles of R-CHOP an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start20 Jul 2025
- Primary completion30 Jul 2025
- Study completion1 Aug 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 CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huber Díaz Fuentes, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134504
- Sponsor's protocol ID
- 98207213
- Status last verified
- May 2025
- First submitted
- 13 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anyone who ask via e-mail
Publications
Bal S, Odujoko O, Fiedler J, Sieber SC, Beck E, Gupta G. Primary follicular lymphoma of the prostate co-existing with grade group 5 prostatic adenocarcinoma and presenting as a PI-RADS lesion 4 on mpMRI. Urol Case Rep. 2024 Mar 12;54:102708. doi: 10.1016/j.eucr.2024.102708. eCollection 2024 May.
PubMed 38550656
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Diffuse Large B Cell Lymphoma (DLBCL) of the Prostate a Case Report
- ClinicalTrials.gov ID
- NCT07134504
- Acronym / sponsor ID
- 98207213
- Conditions
- Prostate Cancer
- Keywords
- lymphoma, diffuse large B cell, urinary tract symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 21 Aug 2025 (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.
A 66-year-old male known case of diabetes and hypertension presented to the urology clinic with a 2-month history of lower urinary tract symptoms (LUTS), particularly poor flow, sense of incomplete bladder emptying, dysuria and hesitancy. Family history was negative for prostate or breast cancer.
On examination, there were signs of anaemia or lymphadenopathy. His abdominal examination was unremarkable with no hepatosplenomegaly, and his digital rectal examination (DRE) revealed an irregular, moderately enlarged nodular prostate.
Detailed description
The patient underwent the following investigations in chronological order:
Laboratory investigations Haemoglobin: 134 g/L. Total leucocyte count: 8.6×109/L without any atypical cells. Platelets: 286×109/L. Prothrombin time/ International normalized ratio (PT/INR): 13/1.1. Creatinine: 1.1 mg/dL. Electrolytes: normal. Urine detailed report: normal. Urine culture and sensitivity: no bacterial growth. Prostate-specific antigen (PSA): 1.54 ng/mL. Radiological imaging Ultrasound of the kidney, ureter and bladder: normal non-hydronephrotic kidneys with 38 g prostate, with post void residual urine volume of 76 mL.
Based on suspicion of prostatic malignancy, he underwent MRI of the pelvis and lumbosacral (L/S) spine, whole body bone scan, and transrectal ultrasound (TRUS) guided 12-core needle biopsy of the prostate.
Bone scan: negative. MRI of the pelvis: 4.8×4.1×3.2 cm prostate with abnormal signal intensity area in the central zone appearing hypointense on T2-weighted image. The prostatic capsule and neurovascular bundles were intact.
Gross examination: TRUS biopsy showed 12 linear core tissues from both the right and left lobes of the prostate, with the largest measuring 1.1 cm.
Microscopic examination: sections from 4 cores out of 12 (2 each from the apical prostatic tissues of the right and left lobes) revealed prostate parenchyma infiltrated by atypical medium-sized to large-sized lymphoid cells arranged in diffuse sheets. These lymphoid cells exhibited scant to moderate amount of eosinophilic cytoplasm and nuclei with irregular contours, dispersed chromatin and occasional prominent nucleoli. The rest of the eight prostate tissue cores revealed benign prostate parenchyma showing glands lined by double-layered epithelium.
Immunohistochemical studies: tumour cells were strongly positive for leucocyte common antigen, CD20 (Pan-B marker), BCL-2 and CD10.The patient received alpha-adrenergic blocker tamsulosin with finasteride for LUTS with good response. For his radicular pain, he received diclofenac sodium and pregabalin. Following discussion in a multidisciplinary tumour board meeting, he received six cycles of R-CHOP (Rrituximab, Cyclophosphamide, Doxorubicin hydrochloride, Vincristine sulfate, and Prednisone) regimen at an outside cancer treatment facility.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 66 Year old male.
Key inclusion criteria (1 listed)
- Patient with primary diffuse large B cell lymphoma
Key exclusion criteria (1 listed)
- Patient with without primary diffuse large B cell lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cancer specific survival
Time frame: through the end of 6 cycles of R-CHOP an average of 6 months
cancer specific survival with R-CHOP
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 21 Aug 2025.
- Results publication: PubMed 38550656Bal S, Odujoko O, Fiedler J, Sieber SC, Beck E, Gupta G. Primary follicular lymphoma of the prostate co-existing with grade group 5 prostatic adenocarcinoma and presenting as a PI-RADS lesion 4 on mpMRI. Urol Case Rep. 2024 Mar 12;54:102708. doi: 10.1016/j.eucr.2024.102708. eCollection 2024 May.
- Individual participant dataSharing planned: Yes. anyone who ask via e-mail
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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, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 1 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: finished, as of the sponsor's last update on 21 Aug 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 Mexico. 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?
cancer specific survival (time frame: through the end of 6 cycles of R-CHOP an average of 6 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 NCT07134504, 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 21 Aug 2025.