Erectile Dysfunction Following Radical ProstatectomyNCT07863388
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy: a Randomized Controlled Trial
A study testing Autologous Platelet Rich Plasma in people with Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
- What is being tested?
- Autologous Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2026to Nov 2029
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years
- Underwent unilateral or bilateral nerve-sparing radical prostatectomy between 1 and 3 years prior to the study
- Good erectile function prior to surgery (IIEF-EF score ≥ 22)
- Erectile dysfunction at inclusion with an IIEF-EF score < 22 without aids
- Acceptance of a pause in other treatments for erectile dysfunction from 4 weeks before baseline (wash-out) until the 1-month follow-up after the last injection
- In a stable relationship lasting at least 6 months with a desire for sexual activity
- Able to understand and accept the study protocol
Who cannot join
- Known psychiatric, neurological and/or endocrinological disease requiring medication (including hypogonadism with total testosterone <12 nmol/l).
- Severe urinary incontinence preventing sexual activity (assessed by a physician at inclusion)
- Clinical or biochemical recurrence of prostate cancer
- Other surgery or radiation therapy in the pelvic region
- Severe cardiac disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or severe symptomatic and/or significant valvular disease
- Use of anti-androgen medication
- Peyronie's disease and/or previous episodes of priapism
- Excessive alcohol consumption (more than 21 units per week)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Urology, Herlev and Gentofte Hospital
Herlev, 2730
Mette LK Schmidt, PDH, +4538681100, Mette.Ladefoged.Kopp.Schmidt@regionh.dk
About this study
Official title: Treatment of Erectile Dysfunction After Radical Prostatectomy With Platelet-Rich Plasma Injections: a Randomized Controlled Trial
This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either two PRP injections or two saline (placebo) injections into the penis, administered one month apart in a double-blind fashion. Erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and at 1, 3, 6, and 12 months after the last injection. The primary objective is to determine whether PRP improves the erectile function domain of the IIEF more than saline at one month after the last injection
Read the detailed description
Erectile dysfunction is common after nerve-sparing radical prostatectomy and may persist despite recovery from the initial nerve injury. Platelet-rich plasma (PRP) is prepared from autologous blood and contains growth factors that may promote angiogenesis and tissue regeneration. Preclinical studies suggest that PRP may improve erectile function after cavernous nerve injury, but PRP remains an experimental treatment, and no published study has specifically evaluated its effect in men with erectile dysfunction following radical prostatectomy.
The hypothesis is that intracavernosal PRP injections improve erectile function more than saline injections in men with erectile dysfunction persisting 1-3 years after nerve-sparing radical prostatectomy.
Eligible participants will be stratified according to unilateral or bilateral nerve-sparing surgery and randomized 1:1 to receive two intracavernosal injections of either autologous PRP or saline, administered one month apart. An unblinded team member who has no direct interaction with participants will prepare the injections. The participant and the physician administering the injection will remain blinded to treatment allocation. Syringes will be covered with opaque material to maintain blinding.
Blood will be collected before each injection in all participants. For participants assigned to PRP, the blood will be used to prepare the treatment. For the first 10 participants assigned to saline, PRP will also be prepared and analysed to verify the platelet concentration achieved with the preparation procedure. Blood collected from the remaining participants assigned to saline will be discarded.
Participants must discontinue other treatments for erectile dysfunction for four weeks before baseline and until the assessment one month after the last injection. Thereafter, other treatments for erectile dysfunction will be permitted and recorded.
Erectile function and other study outcomes will be assessed at baseline and at 1, 3, 6, and 12 months after the last injection. The primary outcome is the between-group difference in change from baseline in the erectile function domain of the International Index of Erectile Function at one month after the last injection.
- Being tested
- Autologous Platelet Rich Plasma, saline solution (placebo)
- Keywords
- Radical Prostatectomy, Erectile Dysfunction, Penile Rehabilitation, Nerve-Sparing Surgery, PRP, Male Urogenital Diseases, Platelet-rich plasma
- Medical subject headings
- Erectile Dysfunction, Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich PlasmaOther
Also called PRP, Platelet-Rich Plasma
A volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections
saline solution (placebo)Other
Also called Placebo
A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | A volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections Receives: Other: Autologous Platelet Rich Plasma |
| Saline Solution (Placebo) | Other | A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections. Receives: Other: saline solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IIEF-EF score from baseline to 1 month after the final treatment session
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using an intention-to-treat analysis.
Measured: From baseline to 1 month post the last intervention
Secondary outcomes (8)
Change in IIEF-EF score at 1 month after the final treatment session - per-protocol analysis
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using a per-protocol analysis.
Measured: From baseline to 1 month post the last intervention
Change in IIEF-EF score at 3, 6, and 12 months after the final treatment session
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 3, 6, and 12 months after the final treatment session. Analyses will be performed using both intention-to-treat and per-protocol populations, comparing the PRP and saline groups.
Measured: From baseline to 12 months post the last intervention
Analyses of participants achieving a clinically significant improvement in IIEF-EF score at 1, 3, 6, and 12 months
Intention-to-treat and per-protocol analyses of the proportion of participants achieving clinically significant improvements in IIEF-EF at 1, 3, 6, and 12 months following the final treatment session with PRP or saline. Clinically significant improvement is defined according to Rosen et al. as an increase of 2 points for mild ED, 5 points for moderate ED, and 7 points for severe ED
Measured: From baseline to 12 months post the last intervention
Change in IIEF domain scores at 1, 3, 6, and 12 months
Changes in the remaining domains of the International Index of Erectile Function (IIEF): orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. As no minimum clinically important difference has been established for these domains, changes in domain scores will be analysed as continuous variables and compared between the PRP and saline groups.
Measured: From baseline to 12 months post the last intervention
Participant satisfaction after treatment
Subjective participant satisfaction following treatment, assessed using the Global Satisfaction Question. This analysis will be performed according to the intention-to-treat principle.
Measured: From baseline to 12 months post last intervention
Use of additional treatments for erectile dysfunction
Use of additional treatments for erectile dysfunction during the study period, including oral medication, intraurethral treatment, intracavernosal injections, vacuum erection devices, and penile implants. The use of additional treatments will be compared between the PRP and saline groups.
Measured: Until 12 months post last intervention.
Treatment effect according to baseline severity of erectile dysfunction
Subgroup analyses of treatment effects according to severity of erectile dysfunction at baseline (recorded just before the first injection). These analyses will be considered exploratory and hypothesis-generating.
Measured: From baseline to 12 months post last intervention
Adverse events following treatment
Incidence and type of adverse events following PRP and saline injections during the study period. All adverse events will be recorded and described in the final study manuscript.
Measured: From baseline to 12 months post last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederikke Bay Toft, Herlev and Gentofte Hospital
- Investigators
- Mikkel Fode, MD, PhD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863388
- Sponsor's protocol ID
- H-25034065
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Erectile Dysfunction After Radical Prostatectomy With Platelet-Rich Plasma Injections: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07863388
- Acronym / sponsor ID
- H-25034065
- Keywords
- Radical Prostatectomy, Erectile Dysfunction, Penile Rehabilitation, Nerve-Sparing Surgery, PRP, Male Urogenital Diseases, Platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 7 Oct 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.
This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either two PRP injections or two saline (placebo) injections into the penis, administered one month apart in a double-blind fashion. Erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and at 1, 3, 6, and 12 months after the last injection. The primary objective is to determine whether PRP improves the erectile function domain of the IIEF more than saline at one month after the last injection
Detailed description
Erectile dysfunction is common after nerve-sparing radical prostatectomy and may persist despite recovery from the initial nerve injury. Platelet-rich plasma (PRP) is prepared from autologous blood and contains growth factors that may promote angiogenesis and tissue regeneration. Preclinical studies suggest that PRP may improve erectile function after cavernous nerve injury, but PRP remains an experimental treatment, and no published study has specifically evaluated its effect in men with erectile dysfunction following radical prostatectomy.
The hypothesis is that intracavernosal PRP injections improve erectile function more than saline injections in men with erectile dysfunction persisting 1-3 years after nerve-sparing radical prostatectomy.
Eligible participants will be stratified according to unilateral or bilateral nerve-sparing surgery and randomized 1:1 to receive two intracavernosal injections of either autologous PRP or saline, administered one month apart. An unblinded team member who has no direct interaction with participants will prepare the injections. The participant and the physician administering the injection will remain blinded to treatment allocation. Syringes will be covered with opaque material to maintain blinding.
Blood will be collected before each injection in all participants. For participants assigned to PRP, the blood will be used to prepare the treatment. For the first 10 participants assigned to saline, PRP will also be prepared and analysed to verify the platelet concentration achieved with the preparation procedure. Blood collected from the remaining participants assigned to saline will be discarded.
Participants must discontinue other treatments for erectile dysfunction for four weeks before baseline and until the assessment one month after the last injection. Thereafter, other treatments for erectile dysfunction will be permitted and recorded.
Erectile function and other study outcomes will be assessed at baseline and at 1, 3, 6, and 12 months after the last injection. The primary outcome is the between-group difference in change from baseline in the erectile function domain of the International Index of Erectile Function at one month after the last injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Other: Autologous Platelet Rich PlasmaA volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections |
| Saline Solution (Placebo) | Other | Other: saline solution (placebo)A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-75 years
- Underwent unilateral or bilateral nerve-sparing radical prostatectomy between 1 and 3 years prior to the study
- Good erectile function prior to surgery (IIEF-EF score ≥ 22)
- Erectile dysfunction at inclusion with an IIEF-EF score < 22 without aids
- Acceptance of a pause in other treatments for erectile dysfunction from 4 weeks before baseline (wash-out) until the 1-month follow-up after the last injection
Key exclusion criteria (8 listed)
- Known psychiatric, neurological and/or endocrinological disease requiring medication (including hypogonadism with total testosterone <12 nmol/l).
- Severe urinary incontinence preventing sexual activity (assessed by a physician at inclusion)
- Clinical or biochemical recurrence of prostate cancer
- Other surgery or radiation therapy in the pelvic region
- Severe cardiac disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or severe symptomatic and/or significant valvular disease
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 |
|---|---|---|
| Autologous Platelet Rich PlasmaAlso: PRP, Platelet-Rich PlasmaA volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections | Other | Platelet Rich Plasma (PRP) |
| saline solution (placebo)Also: PlaceboA volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections. | Other | Saline Solution (Placebo) |
Primary outcome
Change in IIEF-EF score from baseline to 1 month after the final treatment session
Time frame: From baseline to 1 month post the last intervention
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using an intention-to-treat analysis.
8 secondary outcomes
Change in IIEF-EF score at 1 month after the final treatment session - per-protocol analysis
Time frame: From baseline to 1 month post the last intervention
Change in IIEF-EF score at 3, 6, and 12 months after the final treatment session
Time frame: From baseline to 12 months post the last intervention
Analyses of participants achieving a clinically significant improvement in IIEF-EF score at 1, 3, 6, and 12 months
Time frame: From baseline to 12 months post the last intervention
Change in IIEF domain scores at 1, 3, 6, and 12 months
Time frame: From baseline to 12 months post the last intervention
Participant satisfaction after treatment
Time frame: From baseline to 12 months post last intervention
Use of additional treatments for erectile dysfunction
Time frame: Until 12 months post last intervention.
Treatment effect according to baseline severity of erectile dysfunction
Time frame: From baseline to 12 months post last intervention
Adverse events following treatment
Time frame: From baseline to 12 months post last intervention
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mikkel Fode, MD, PhD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet Rich Plasma in people with Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 Oct 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 Denmark. 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 Frederikke Bay Toft, MD (+4538689927, frederikke.bay.toft.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IIEF-EF score from baseline to 1 month after the final treatment session (time frame: From baseline to 1 month post the last intervention). 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 7 Oct 2026.