ProstatectomyNCT07348367
A Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.
A study testing Radical Prostatectomy and Precision Prostatectomy in people with Prostatectomy, run by Henry Ford Health System at 1 site in United States.
Trial summary
Prostate cancer (PCa) management for low- and intermediate-risk patients often involves radical prostatectomy (RP), which achieves oncologic control but is associated with significant functional impairments, such as erectile dysfunction (50-70%) and urinary incontinence (5-20%). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatectomy
- What is being tested?
- Radical Prostatectomy and Precision Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to Dec 2028
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate cancer patients receiving treatment at Henry Ford Health from the investigator or co-investigator who opt for surgery.
- Prostate-specific antigen (PSA) ≤20 ng/mL
- Clinical stage ≤cT2
- Dominant unilateral lesion with Gleason ≤4+3 on biopsy
- No Gleason ≥4 contralaterally
- Preoperative SHIM score ≥17 (with or without phosphodiesterase-5 inhibitor use)
Who cannot join
- • Androgen deprivation therapy within 6 months.
- Nodal positive disease
- Metastatic disease
- Prior prostate cancer therapy (e.g., radiation, HIFU).
- Significant comorbidities precluding surgery or life expectancy <5 years as defined by the Prostate Cancer Comorbidity Index [5].
- Any previous cancer diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Firas Abdollah, MD, 313-673-7463, fabdoll1@hfhs.org
Alex Stephens, MS, 313-556-7918, asteph11@hfhs.org
About this study
Official title: A Randomized Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.
Prostate cancer (PCa) management for low- and intermediate-risk patients often involves radical prostatectomy (RP), which achieves oncologic control but is associated with significant functional impairments, such as erectile dysfunction (50-70%) and urinary incontinence (5-20%). To address these issues, precision prostatectomy (PP) has emerged as a novel surgical approach that preserves functional structures while removing >90% of prostate tissue.
PP is thought to provide superior functional outcomes with acceptable oncological control by preserving the capsule, seminal vesicle (SV), and the surrounding neuronal nitric oxide synthase (nNOS) producing nerves on the side opposite to the dominant nodule while maximizing prostatic tissue removal. Early reports of PP demonstrate promising functional outcomes, with 90% of patients retaining sexual potency (Sexual Health Inventory for Men [SHIM] score ≥17) and 100% achieving continence (0-1 pads/day) by 12 months postoperatively. Importantly, PP only requires a different surgical technique, no more equipment, time, or labor is required. This means that there is no additional charge to patients, and it is covered the same by health insurance.
Read more
While there are early results suggesting the superiority of PP, no randomized trials have yet to be performed. This study has two main aims: to demonstrate superiority of PP in terms of functional recovery while also establishing non-inferiority in oncologic outcomes compared to RP. This dual objective reflects the potential of PP to improve quality of life without compromising cancer control.
Eligible patients will be randomized to either RP, which is the current standard of care, or PP using random blocked randomization using the Zelen design.
The outcomes of interest will be measured at 12 months post-surgery. Functional outcomes will be measured using SHIM scores at 12 months and the number of pads used per day. Meanwhile, oncological outcomes will be measured by whether patients have received secondary prostate cancer treatment at 12 months post-surgery. These items are collected as part of standard of care of all patients 12 months after prostatectomy. RP and PP patients' sexual function recovery (SHIM ≥17 vs SHIM < 17), as well as the proportion reaching continence (≤1 pad per day, > 1 pad per day) will be compared.
RP has been shown to be effective in terms of oncological outcomes, though it has also been shown to be related to incontinence and erectile dysfunction. Early results have suggested that PP is superior in terms of functional outcomes while being as good as RP in terms of oncological outcomes, though no randomized trials have been conducted. This trial will address this literature gap and could lead to patients receiving care that is as effective ontologically and superior in terms of functional recovery as the current standard of care. This could lead to improved quality of life for patients after surgery. Considering that prostate cancer is the most common non-cutaneous carcinoma among men in the United States, this has the potential to help thousands of men per year by improving their quality of life without sacrificing oncological outcomes.
- Conditions
- Prostatectomy
- Being tested
- Radical Prostatectomy, Precision Prostatectomy
- Keywords
- Prostate Cancer, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
Also called Prostatectomy
In radical prostatectomies, the entire prostate as well as much of the surrounding tissue is removed.
Precision ProstatectomyProcedure or surgery
The surgical approach is very similar to a radical prostatectomy. The difference is that in precision prostatectomy, some of the prostate, including the nerves which might be integral to continence and erectile function are protected and not removed, unlike with traditional radical prostatectomies.
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy | Active comparator | This arm is the control arm and consists of the current standard of care. Patients in this arm receive a radical prostatectomy. Receives: Procedure: Radical Prostatectomy |
| Precision Prostatectomy | Experimental | This arm is the treatment arm and consists of patients who receive a Precision Prostatectomy. Receives: Procedure: Precision Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Health
Patients' sexual health and function is measured by the Sexual Health Inventory for Men (SHIM). A SHIM score > 16 is considered sexually healthy.
Measured: Before surgery, 3 months post-surgery, 12 months post-surgery
Social Continence
Continence is determined by the number of pads used per day by patients. Social continence is defined as < 2 pads per day.
Measured: 12 months post-surgery.
Secondary outcomes (1)
Oncological outcomes
The number of patients who undergo secondary treatment.
Measured: 12-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start12 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Firas Abdollah, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348367
- Sponsor's protocol ID
- 18404-01
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time we do not plan on making a deidentified dataset and PHI cannot be shared per institutional policies. We will consider sharing deidentified data upon request.
Publications
Sood A, Jeong W, Keeley J, Abdollah F, Hassan O, Gupta N, Menon M. Subtotal surgical therapy for localized prostate cancer: a single-center precision prostatectomy experience in 25 patients, and SEER-registry data analysis. Transl Androl Urol. 2021 Jul;10(7):3155-3166. doi: 10.21037/tau-20-1476.
PubMed 34430418Capogrosso P, Vertosick EA, Benfante NE, Eastham JA, Scardino PJ, Vickers AJ, Mulhall JP. Are We Improving Erectile Function Recovery After Radical Prostatectomy? Analysis of Patients Treated over the Last Decade. Eur Urol. 2019 Feb;75(2):221-228. doi: 10.1016/j.eururo.2018.08.039. Epub 2018 Sep 17.
PubMed 30237021Resnick MJ, Koyama T, Fan KH, Albertsen PC, Goodman M, Hamilton AS, Hoffman RM, Potosky AL, Stanford JL, Stroup AM, Van Horn RL, Penson DF. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013 Jan 31;368(5):436-45. doi: 10.1056/NEJMoa1209978.
PubMed 23363497Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, Vallancien G. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol. 2002 Sep;168(3):945-9. doi: 10.1016/S0022-5347(05)64548-X.
PubMed 12187196Xiao H, Tan F, Goovaerts P, Ali A, Adunlin G, Huang Y, Gwede C. Construction of a comorbidity index for prostate cancer patients linking state cancer registry with inpatient and outpatient data. J Registry Manag. 2013 Winter;40(4):159-64.
PubMed 24625768Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
PubMed 10637462Sood A, Jeong W, Taneja K, Abdollah F, Palma-Zamora I, Arora S, Gupta N, Menon M. The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study. BMJ Surg Interv Health Technol. 2019 Aug 19;1(1):e000002. doi: 10.1136/bmjsit-2019-000002. eCollection 2019.
PubMed 35047770
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.
- ClinicalTrials.gov ID
- NCT07348367
- Acronym / sponsor ID
- 18404-01
- Conditions
- Prostatectomy
- Keywords
- Prostate Cancer, Prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (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) management for low- and intermediate-risk patients often involves radical prostatectomy (RP), which achieves oncologic control but is associated with significant functional impairments, such as erectile dysfunction (50-70%) and urinary incontinence (5-20%). To address these issues, precision prostatectomy (PP) has emerged as a novel surgical approach that preserves functional structures while removing >90% of prostate tissue.
PP is thought to provide superior functional outcomes with acceptable oncological control by preserving the capsule, seminal vesicle (SV), and the surrounding neuronal nitric oxide synthase (nNOS) producing nerves on the side opposite to the dominant nodule while maximizing prostatic tissue removal. Early reports of PP demonstrate promising functional outcomes, with 90% of patients retaining sexual potency (Sexual Health Inventory for Men [SHIM] score ≥17) and 100% achieving continence (0-1 pads/day) by 12 months postoperatively. Importantly, PP only requires a different surgical technique, no more equipment, time, or labor is required. This means that there is no additional charge to patients, and it is covered the same by health insurance.
While there are early results suggesting the superiority of PP, no randomized trials have yet to be performed. This study has two main aims: to demonstrate superiority of PP in terms of functional recovery while also establishing non-inferiority in oncologic outcomes compared to RP. This dual objective reflects the potential of PP to improve quality of life without compromising cancer control.
Eligible patients will be randomized to either RP, which is the current standard of care, or PP using random blocked randomization using the Zelen design.
The outcomes of interest will be measured at 12 months post-surgery. Functional outcomes will be measured using SHIM scores at 12 months and the number of pads used per day. Meanwhile, oncological outcomes will be measured by whether patients have received secondary prostate cancer treatment at 12 months post-surgery. These items are collected as part of standard of care of all patients 12 months after prostatectomy. RP and PP patients' sexual function recovery (SHIM ≥17 vs SHIM < 17), as well as the proportion reaching continence (≤1 pad per day, > 1 pad per day) will be compared.
RP has been shown to be effective in terms of oncological outcomes, though it has also been shown to be related to incontinence and erectile dysfunction. Early results have suggested that PP is superior in terms of functional outcomes while being as good as RP in terms of oncological outcomes, though no randomized trials have been conducted. This trial will address this literature gap and could lead to patients receiving care that is as effective ontologically and superior in terms of functional recovery as the current standard of care. This could lead to improved quality of life for patients after surgery. Considering that prostate cancer is the most common non-cutaneous carcinoma among men in the United States, this has the potential to help thousands of men per year by improving their quality of life without sacrificing oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy | Active comparator | Procedure: Radical ProstatectomyThis arm is the control arm and consists of the current standard of care. Patients in this arm receive a radical prostatectomy. |
| Precision Prostatectomy | Experimental | Procedure: Precision ProstatectomyThis arm is the treatment arm and consists of patients who receive a Precision Prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate cancer patients receiving treatment at Henry Ford Health from the investigator or co-investigator who opt for surgery.
- Prostate-specific antigen (PSA) ≤20 ng/mL
- Clinical stage ≤cT2
- Dominant unilateral lesion with Gleason ≤4+3 on biopsy
- No Gleason ≥4 contralaterally
Key exclusion criteria (6 listed)
- • Androgen deprivation therapy within 6 months.
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 |
|---|---|---|
| Radical ProstatectomyAlso: ProstatectomyIn radical prostatectomies, the entire prostate as well as much of the surrounding tissue is removed. | Procedure or surgery | Radical Prostatectomy |
| Precision ProstatectomyThe surgical approach is very similar to a radical prostatectomy. The difference is that in precision prostatectomy, some of the prostate, including the nerves which might be integral to continence and erectile function are protected and not removed, unlike with traditional radical prostatectomies. | Procedure or surgery | Precision Prostatectomy |
Primary outcome
Sexual Health
Time frame: Before surgery, 3 months post-surgery, 12 months post-surgery
Patients' sexual health and function is measured by the Sexual Health Inventory for Men (SHIM). A SHIM score > 16 is considered sexually healthy.
Social Continence
Time frame: 12 months post-surgery.
Continence is determined by the number of pads used per day by patients. Social continence is defined as < 2 pads per day.
1 secondary outcome
Oncological outcomes
Time frame: 12-months post-surgery
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 16 Jan 2026.
- Background: PubMed 34430418Sood A, Jeong W, Keeley J, Abdollah F, Hassan O, Gupta N, Menon M. Subtotal surgical therapy for localized prostate cancer: a single-center precision prostatectomy experience in 25 patients, and SEER-registry data analysis. Transl Androl Urol. 2021 Jul;10(7):3155-3166. doi: 10.21037/tau-20-1476.
- Background: PubMed 30237021Capogrosso P, Vertosick EA, Benfante NE, Eastham JA, Scardino PJ, Vickers AJ, Mulhall JP. Are We Improving Erectile Function Recovery After Radical Prostatectomy? Analysis of Patients Treated over the Last Decade. Eur Urol. 2019 Feb;75(2):221-228. doi: 10.1016/j.eururo.2018.08.039. Epub 2018 Sep 17.
- Background: PubMed 23363497Resnick MJ, Koyama T, Fan KH, Albertsen PC, Goodman M, Hamilton AS, Hoffman RM, Potosky AL, Stanford JL, Stroup AM, Van Horn RL, Penson DF. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013 Jan 31;368(5):436-45. doi: 10.1056/NEJMoa1209978.
- Background: PubMed 12187196Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, Vallancien G. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol. 2002 Sep;168(3):945-9. doi: 10.1016/S0022-5347(05)64548-X.
- Background: PubMed 24625768Xiao H, Tan F, Goovaerts P, Ali A, Adunlin G, Huang Y, Gwede C. Construction of a comorbidity index for prostate cancer patients linking state cancer registry with inpatient and outpatient data. J Registry Manag. 2013 Winter;40(4):159-64.
- Background: PubMed 10637462Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Background: PubMed 35047770Sood A, Jeong W, Taneja K, Abdollah F, Palma-Zamora I, Arora S, Gupta N, Menon M. The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study. BMJ Surg Interv Health Technol. 2019 Aug 19;1(1):e000002. doi: 10.1136/bmjsit-2019-000002. eCollection 2019.
- Individual participant dataSharing planned: No. At this time we do not plan on making a deidentified dataset and PHI cannot be shared per institutional policies. We will consider sharing deidentified data upon request.
Related trials for Prostatectomy
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 3
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Prostatic Neoplasms
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy and Precision Prostatectomy in people with Prostatectomy, run by Henry Ford Health System at 1 site 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 6 inclusion and 6 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 16 Jan 2026. 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 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 Firas Abdollah, MD, FEBU (313-673-7463, fabdoll1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Health (time frame: Before surgery, 3 months post-surgery, 12 months post-surgery). The study lists 2 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 NCT07348367, which also lists 7 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 16 Jan 2026.