Prostate CancerNCT06705803
Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)
An observational study of Prostate Cancer, run by University of Chicago at 2 sites in United States.
Trial summary
Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2024to Jun 2029
- 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 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study will collect data on all consecutive patients who have undergone prostate ablation at University of Chicago Medical Center without any exclusions. Patients will be consented at the UCMC campus as well as at River East.
Who may be able to join
- Male sex
- ≥22 years of age
- Histologic diagnosis of prostate cancer
- Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
- Prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins
Who cannot join
- Under 21 Years of age.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Cinncinatti
Cincinnati, Ohio, 45221
Sadhna Verma, MD, vermasm@ucmail.uc.edu
Shima Tayebi, tayebisa@ucmail.uc.edu
- Recruiting
The University of Chicago
Hyde Park, Illinois, 60637
Abhinav Sidana, MD
Leila Yazdanbakhsh, 7738345087, leila.yazdanbakhsh@bsd.uchicago.edu
About this study
Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Due to advances in screening and imaging technology, PCa is now detected much earlier in its disease course. Prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (AS) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. This treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy.
The purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Patients with biopsy-proven prostate cancer of any Gleason Grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. Historical data from 2017 to the present time will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate AblationProcedure or surgery
Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Patients Undergoing Prostate Ablation | Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Receives: Procedure: Prostate Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes
Descriptive summarization of Prostate specific antigen (PSA) and its derivatives
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of prostate biopsy
Descriptive summarization of prostate biopsy to represent clinicopathologic, interventions, and oncological outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of biomarkers
Descriptive summarization of biomarkers to represent clinicopathologic, interventions, and oncological outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of imaging findings
Descriptive summarization of imaging findings to represent clinicopathologic, interventions, and oncological outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of urination function
Descriptive summarization of urination function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of bowel function
Descriptive summarization of bowel function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of sexual function
Descriptive summarization of sexual function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Number of Participants with descriptive summarization of the overall quality of life parameters
Descriptive summarization of the overall quality of life parameters to represent clinicopathologic, interventions, and genitourinary functional outcomes
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.
Data measured on a continuous scale will be expressed as a mean, standard deviation when normally distributed and as a median and interquartile range, when non-normally distributed.
Measured: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start21 Jun 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Abhinav Sidana, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705803
- Sponsor's protocol ID
- IRB 24-0111
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)
- ClinicalTrials.gov ID
- NCT06705803
- Acronym / sponsor ID
- IRB 24-0111
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Nov 2024 (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.
Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Due to advances in screening and imaging technology, PCa is now detected much earlier in its disease course. Prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (AS) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. This treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy.
The purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Patients with biopsy-proven prostate cancer of any Gleason Grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. Historical data from 2017 to the present time will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients Undergoing Prostate Ablation | – | Procedure: Prostate AblationPatients with prostate cancer undergoing prostate ablation for the management of prostate cancer. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will collect data on all consecutive patients who have undergone prostate ablation at University of Chicago Medical Center without any exclusions. Patients will be consented at the UCMC campus as well as at River East.
Key inclusion criteria (5 listed)
- Male sex
- ≥22 years of age
- Histologic diagnosis of prostate cancer
- Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
- Prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins
Key exclusion criteria (1 listed)
- Under 21 Years of age.
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 |
|---|---|---|
| Prostate AblationPatients with prostate cancer undergoing prostate ablation for the management of prostate cancer. | Procedure or surgery | Prostate Cancer Patients Undergoing Prostate Ablation |
Primary outcome
Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of Prostate specific antigen (PSA) and its derivatives
Number of Participants with descriptive summarization of prostate biopsy
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of prostate biopsy to represent clinicopathologic, interventions, and oncological outcomes
Number of Participants with descriptive summarization of biomarkers
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of biomarkers to represent clinicopathologic, interventions, and oncological outcomes
Number of Participants with descriptive summarization of imaging findings
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of imaging findings to represent clinicopathologic, interventions, and oncological outcomes
Number of Participants with descriptive summarization of urination function
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of urination function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Number of Participants with descriptive summarization of bowel function
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of bowel function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Number of Participants with descriptive summarization of sexual function
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of sexual function to represent clinicopathologic, interventions, and genitourinary functional outcomes
Number of Participants with descriptive summarization of the overall quality of life parameters
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Descriptive summarization of the overall quality of life parameters to represent clinicopathologic, interventions, and genitourinary functional outcomes
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.
Time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Abhinav Sidana, MD principal investigator
University of Chicago
2 sites 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 University of Chicago at 2 sites in United States.
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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Abhinav Sidana, MD (773-834-5087, abhinav.sidana@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes (time frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.