Prostate Cancer (Adenocarcinoma)Phase 2REDI-CaPNCT07302451
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
A Phase 2 study testing Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer (Adenocarcinoma), run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2026to 23 Feb 2031
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)
- Age > 18 years;
- Diagnosis of prostate cancer via transperineal core biopsy;
- Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL, and Gleason score 7(4+3); ISUP grade 3);
- Signed informed consent for REDI-CaP protocol;
- Signed consent for REDI-CaP data processing;
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- Prostate volume ≤ 80 cc;
- No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate);
- Performance status: 0-1;
- Negative total-body CT with contrast and bone scan for metastases;
- Negative PSMA PET for secondary lesions;
- IIEF-5 score: ≥ 8;
- Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.
Who cannot join
- Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;
- Exhibit erectile dysfunction at baseline (IIEF-5 score: < 8);
- Show positive PSMA PET results for metastases or pelvic lymph nodes;
- Have capsular involvement documented by multiparametric prostate MRI;
- Have contraindications to radiotherapy and/or hormone therapy;
- Are unable to undergo MRI;
- Cannot adhere to periodic tests and follow-ups;
- Refuse or have contraindications to the implantation of intraprostatic fiducials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli
Naples, 80131
Simona Mercogliano, Study Coordinator, simona.mercogliano@istitutotumori.na.it
About this study
Official title: REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery
The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are:
- How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy?
- How do the details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.
Read the detailed description
Assessment of the International Index of Erectile Function-5 (IIEF-5) score at six months after hormonal therapy cessation, indicating recovery in at least 70% of the study population. Evaluation of Erectile Function Recovery 6 Months After Hormonal Therapy Completion The success of the study will be determined if erectile function recovery is observed in at least 70% of the population 6 months after the completion of hormonal therapy. Definition of "Erectile Function Recovery" for Individual Patients: A subject will be considered to have recovered erectile function if, at 6 months after the completion of hormonal therapy (Relugolix), their IIEF5 (International Index of Erectile Function - 5) score meets one of the following conditions:
- Achieving an IIEF5 score ≥ 17: This score indicates mild erectile dysfunction or no erectile dysfunction (as per IIEF5 categories: 22-25 no erectile dysfunction, 17-21 mild dysfunction). AND/OR;
- Significant increase in IIEF5 score compared to baseline: An increase of at least 5 points compared to the baseline (pre-treatment) IIEF5 score, indicating a clinically significant improvement in erectile function.
Recovery will only be evaluated in patients who had erectile dysfunction present (IIEF5 < 22) at baseline. The study will be considered "successful" if the proportion of patients meeting the individual definition of "erectile function recovery" (as specified above) at 6 months after the completion of hormonal therapy is greater than or equal to 70% of the studied population.
The secondary endpoints of this study aim to provide a comprehensive understanding of both the functional and oncological outcomes following the cessation of hormonal therapy with Relugolix. One key endpoint is the time to sexual function recovery (SFRT), defined as the interval between hormonal therapy cessation and the point at which a patient achieves an IIEF-5 score of 8 or higher, maintained across two consecutive assessments. This threshold was selected to reflect a clinically meaningful level of erectile function recovery, particularly in patients with moderate to severe dysfunction at baseline, and aligns with established literature and the study's primary endpoint criteria. Recovery will be assessed by comparing post-treatment IIEF-5 scores with each patient's baseline value. Additionally, the study will investigate the correlation between erectile function recovery and radiation dose exposure to critical anatomical structures involved in sexual function, including the penile bulb, crura, internal pudendal arteries, periprostatic neurovascular bundles, and testes, aiming to identify dose-dependent effects on functional outcomes. Other secondary endpoints include biochemical progression-free survival (bPFS), measured according to the Phoenix criteria (nadir PSA + 2 ng/mL), as well as local control (time to local recurrence or last follow-up without recurrence) and distant progression-free survival (dPFS), defined as the time to detection of distant metastases. The study will also evaluate acute and late urinary and rectal toxicity, using the RTOG criteria and International Prostate Symptom Score (IPSS) to assess the genitourinary and gastrointestinal side effects of therapy. To gauge broader patient well-being, quality of life (QoL) will be monitored using validated tools including the EORTC QLQ-C30, EORTC PR25, and IIEF-5 questionnaires. Furthermore, the study incorporates a financial toxicity assessment using the PROFFIT questionnaire, which measures the economic burden of treatment from the patient's perspective. Lastly, overall survival (OS) will be tracked, defined as the time from treatment initiation to death from any cause or the date of last follow-up, thereby offering a complete view of treatment impact across survival, function, toxicity, and patient-reported outcomes.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Erectile Function Recovery, Relugolix, Androgen Deprivation Therapy (ADT), Stereotactic Body Radiotherapy (SBRT), Cyberknife System, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)Combination product
Participants will receive oral androgen deprivation therapy (ADT) with Relugolix (120 mg daily for 6 months) and stereotactic body radiotherapy (SBRT) via CyberKnife®. ADT includes a neoadjuvant phase (months 1-3), concurrent SBRT phase (month 4), and adjuvant phase (months 5-6). About 7-10 days before SBRT, 3-4 intraprostatic fiducial markers will be implanted. SBRT consists of 5 fractions of 7.25 Gy (total 36.25 Gy) delivered over two weeks. Planning involves contrast-enhanced CT, with defined CTV and PTV, and sparing of organs at risk. Treatment uses real-time image guidance and motion tracking. The regimen aims to optimize tumor control while minimizing toxicity. Patients are monitored using RTOG criteria, quality of life questionnaires, PSA/testosterone levels, and financial toxicity assessments over an 12-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Unfavorable Intermediate-Risk Prostate Cancer | Experimental | This single arm study includes male patients over 18 years of age with histologically confirmed unfavorable intermediate-risk prostate cancer, defined as clinical stage T2b-T2c, PSA ≤ 20 ng/mL, Gleason score 7 (4+3), and ISUP grade 3. Participants must have a prostate volume < 80 cc, preserved erectile function (IIEF-5 > 8), ECOG performance status 0-1, and no evidence of capsular invasion or metastatic disease (based on multiparametric MRI, PSMA PET, CT with contrast, and bone scan). Receives: Combination Product: Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success
Assessment of erectile function recovery 6 months after cessation of hormonal therapy (Relugolix), using the International Index of Erectile Function-5 (IIEF-5). Recovery is defined as either (1) an IIEF-5 score ≥17 (indicating mild or no erectile dysfunction) and/or (2) an increase of ≥5 points from baseline. Only patients with baseline IIEF-5 <22 (i.e., some degree of erectile dysfunction) will be included in the analysis. The study will be considered successful if ≥70% of the eligible population meets the recovery criteria at the 6-month evaluation following ADT completion.
Measured: 6 months after completion of hormonal therapy (Relugolix)
Secondary outcomes (1)
Time to Sexual Function Recovery and Secondary Clinical Outcomes
Time from cessation of hormonal therapy to recovery of sexual function, defined as achieving and maintaining an IIEF-5 score ≥8 for at least two consecutive assessments. This threshold reflects clinically meaningful erectile function based on literature and the study's primary endpoint. Recovery will be evaluated relative to baseline. Correlations will be explored between recovery and radiation dose to critical structures (penile bulb, crura, internal pudendal artery, neurovascular bundles, testes). Additional outcomes include bPFS (Phoenix criteria), local control, dPFS, OS, urinary/rectal toxicity (RTOG, IPSS), QoL (EORTC QLQ-C30, PR25, IIEF-5), and financial toxicity (PROFFIT).
Measured: From end of hormonal therapy to 36 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start23 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion23 Feb 2031 (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 Prostate Cancer (Adenocarcinoma)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossella Di Franco, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302451
- Sponsor's protocol ID
- INT IRCCS Fondazione Pascale
- Other IDs
- EUCT number: 2025-521170-33-00
- Acronym
- REDI-CaP
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Franco R, Mercogliano S, Mottareale R, Borzillo V, Scipilliti E, Serra M, Buonanno F, Ametrano G, Perrone F, Piccirillo MC, Pignata S, Rossetti S, Perdona S, Franzese D, Izzo A, Muscariello R, Grimaldi G, Castaldo L, Lastoria S, Di Gennaro F, Raddi M, Petrillo A, Simonetti I, Cavalcanti E, De Falco R, di Franco MA, Maiolino P, Pagliuca MI, Roberta D, Vincenzo R. Study protocol on quality of life and erectile function recovery in unfavorable intermediate-risk prostate cancer: REDI-CaP trial. Future Oncol. 2026 Aug 27:1-8. doi: 10.1080/14796694.2026.2723713. Online ahead of print.
PubMed 42656189
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery
- ClinicalTrials.gov ID
- NCT07302451
- Acronym / sponsor ID
- REDI-CaP / INT IRCCS Fondazione Pascale
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Erectile Function Recovery, Relugolix, Androgen Deprivation Therapy (ADT), Stereotactic Body Radiotherapy (SBRT), Cyberknife System, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 23 Feb 2031 (estimated)
- First posted
- 24 Dec 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.
The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are:
- How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy?
- How do the details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.
Detailed description
Assessment of the International Index of Erectile Function-5 (IIEF-5) score at six months after hormonal therapy cessation, indicating recovery in at least 70% of the study population. Evaluation of Erectile Function Recovery 6 Months After Hormonal Therapy Completion The success of the study will be determined if erectile function recovery is observed in at least 70% of the population 6 months after the completion of hormonal therapy. Definition of "Erectile Function Recovery" for Individual Patients: A subject will be considered to have recovered erectile function if, at 6 months after the completion of hormonal therapy (Relugolix), their IIEF5 (International Index of Erectile Function - 5) score meets one of the following conditions:
- Achieving an IIEF5 score ≥ 17: This score indicates mild erectile dysfunction or no erectile dysfunction (as per IIEF5 categories: 22-25 no erectile dysfunction, 17-21 mild dysfunction). AND/OR;
- Significant increase in IIEF5 score compared to baseline: An increase of at least 5 points compared to the baseline (pre-treatment) IIEF5 score, indicating a clinically significant improvement in erectile function.
Recovery will only be evaluated in patients who had erectile dysfunction present (IIEF5 < 22) at baseline. The study will be considered "successful" if the proportion of patients meeting the individual definition of "erectile function recovery" (as specified above) at 6 months after the completion of hormonal therapy is greater than or equal to 70% of the studied population.
The secondary endpoints of this study aim to provide a comprehensive understanding of both the functional and oncological outcomes following the cessation of hormonal therapy with Relugolix. One key endpoint is the time to sexual function recovery (SFRT), defined as the interval between hormonal therapy cessation and the point at which a patient achieves an IIEF-5 score of 8 or higher, maintained across two consecutive assessments. This threshold was selected to reflect a clinically meaningful level of erectile function recovery, particularly in patients with moderate to severe dysfunction at baseline, and aligns with established literature and the study's primary endpoint criteria. Recovery will be assessed by comparing post-treatment IIEF-5 scores with each patient's baseline value. Additionally, the study will investigate the correlation between erectile function recovery and radiation dose exposure to critical anatomical structures involved in sexual function, including the penile bulb, crura, internal pudendal arteries, periprostatic neurovascular bundles, and testes, aiming to identify dose-dependent effects on functional outcomes. Other secondary endpoints include biochemical progression-free survival (bPFS), measured according to the Phoenix criteria (nadir PSA + 2 ng/mL), as well as local control (time to local recurrence or last follow-up without recurrence) and distant progression-free survival (dPFS), defined as the time to detection of distant metastases. The study will also evaluate acute and late urinary and rectal toxicity, using the RTOG criteria and International Prostate Symptom Score (IPSS) to assess the genitourinary and gastrointestinal side effects of therapy. To gauge broader patient well-being, quality of life (QoL) will be monitored using validated tools including the EORTC QLQ-C30, EORTC PR25, and IIEF-5 questionnaires. Furthermore, the study incorporates a financial toxicity assessment using the PROFFIT questionnaire, which measures the economic burden of treatment from the patient's perspective. Lastly, overall survival (OS) will be tracked, defined as the time from treatment initiation to death from any cause or the date of last follow-up, thereby offering a complete view of treatment impact across survival, function, toxicity, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unfavorable Intermediate-Risk Prostate Cancer | Experimental | Combination Product: Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)This single arm study includes male patients over 18 years of age with histologically confirmed unfavorable intermediate-risk prostate cancer, defined as clinical stage T2b-T2c, PSA ≤ 20 ng/mL, Gleason score 7 (4+3), and ISUP grade 3. Participants must have a prostate volume < 80 cc, preserved erectile function (IIEF-5 > 8), ECOG performance status 0-1, and no evidence of capsular invasion or metastatic disease (based on multiparametric MRI, PSMA PET, CT with contrast, and bone scan). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)
- Age > 18 years;
- Diagnosis of prostate cancer via transperineal core biopsy;
- Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL, and Gleason score 7(4+3); ISUP grade 3);
- Signed informed consent for REDI-CaP protocol;
Key exclusion criteria (8 listed)
- Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;
- Exhibit erectile dysfunction at baseline (IIEF-5 score: < 8);
- Show positive PSMA PET results for metastases or pelvic lymph nodes;
- Have capsular involvement documented by multiparametric prostate MRI;
- Have contraindications to radiotherapy and/or hormone therapy;
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 |
|---|---|---|
| Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)Participants will receive oral androgen deprivation therapy (ADT) with Relugolix (120 mg daily for 6 months) and stereotactic body radiotherapy (SBRT) via CyberKnife®. ADT includes a neoadjuvant phase (months 1-3), concurrent SBRT phase (month 4), and adjuvant phase (months 5-6). About 7-10 days before SBRT, 3-4 intraprostatic fiducial markers will be implanted. SBRT consists of 5 fractions of 7.25 Gy (total 36.25 Gy) delivered over two weeks. Planning involves contrast-enhanced CT, with defined CTV and PTV, and sparing of organs at risk. Treatment uses real-time image guidance and motion tracking. The regimen aims to optimize tumor control while minimizing toxicity. Patients are monitored using RTOG criteria, quality of life questionnaires, PSA/testosterone levels, and financial toxicity assessments over an 12-month follow-up. | Combination product | Unfavorable Intermediate-Risk Prostate Cancer |
Primary outcome
Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success
Time frame: 6 months after completion of hormonal therapy (Relugolix)
Assessment of erectile function recovery 6 months after cessation of hormonal therapy (Relugolix), using the International Index of Erectile Function-5 (IIEF-5). Recovery is defined as either (1) an IIEF-5 score ≥17 (indicating mild or no erectile dysfunction) and/or (2) an increase of ≥5 points from baseline. Only patients with baseline IIEF-5 <22 (i.e., some degree of erectile dysfunction) will be included in the analysis. The study will be considered successful if ≥70% of the eligible population meets the recovery criteria at the 6-month evaluation following ADT completion.
1 secondary outcome
Time to Sexual Function Recovery and Secondary Clinical Outcomes
Time frame: From end of hormonal therapy to 36 months post-treatment
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 21 Jul 2026.
- Derived from this study: PubMed 42656189Di Franco R, Mercogliano S, Mottareale R, Borzillo V, Scipilliti E, Serra M, Buonanno F, Ametrano G, Perrone F, Piccirillo MC, Pignata S, Rossetti S, Perdona S, Franzese D, Izzo A, Muscariello R, Grimaldi G, Castaldo L, Lastoria S, Di Gennaro F, Raddi M, Petrillo A, Simonetti I, Cavalcanti E, De Falco R, di Franco MA, Maiolino P, Pagliuca MI, Roberta D, Vincenzo R. Study protocol on quality of life and erectile function recovery in unfavorable intermediate-risk prostate cancer: REDI-CaP trial. Future Oncol. 2026 Aug 27:1-8. doi: 10.1080/14796694.2026.2723713. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer (Adenocarcinoma), run by National Cancer Institute, Naples 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 13 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: looking for participants now, as of the sponsor's last update on 21 Jul 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rossella Di Franco, Radiation Oncologist (+39 08117770569, r.difranco@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success (time frame: 6 months after completion of hormonal therapy (Relugolix)). 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 NCT07302451, 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 Jul 2026.