Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
50
Countries
1
Sites
1
Prostate Cancer
To evaluate the recovery of erectile function at six months after hormonal therapy cessation compared to baseline.
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Nov 2025 → ongoing
- Decision date (initial)
- 2025-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To evaluate the recovery of erectile function at six months after hormonal therapy cessation compared to baseline.
Secondary objectives 10
- Assess the time to recovery of erectile function following hormonal therapy cessation;
- Evaluate the correlation between dosimetric parameters and erectile function
- Determine biochemical progression-free survival (bPFS)
- Assess local control
- Evaluate distant metastasis-free survival (dPFS
- Assess the toxicity profile of radiotherapy
- Evaluate patient quality of life (QoL)
- Investigate financial toxicity
- Assess overall survival (OS)
- Signed informed consent for REDI-CaP protocol Version 1.0 dated 05.10.2024
Conditions and MedDRA coding
Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- 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 consent for REDI-CaP data processing Version 1.0 dated 05.10.2024
- 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.
Exclusion criteria 8
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 9
- Time from hormonal therapy cessation to sexual function recovery relative to pre-treatment levels (SFRT)
- Correlation of erectile function recovery with dose to the penile bulb, crura, internal pudendal artery, periprostatic neurovascular bundles, and testes
- bPFS per Phoenix criteria (nadir + 2 ng/mL)
- Local control, defined as time from treatment to local recurrence or last follow-up
- dPFS, defined as time from treatment to distant metastases or last follow-up
- Acute and late urinary and rectal toxicity, measured using RTOG and IPSS scales
- QoL scores from questionnaires (EORTC QLQ-C30, PR25, IIEF-5)
- Financial toxicity assessment (PROFFIT questionnaire)
- OS, defined as time from treatment to death or last follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Orgovyx 120 mg film-coated tablets
PRD10359492 · Product
- Active substance
- Relugolix
- Substance synonyms
- TAK-385
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX04 — -
- Marketing authorisation
- EU/1/22/1642/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Rossella Di Franco
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Rossella Di Franco
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-11-05 | 2026-02-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 24 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol REDICaP eng red | 3 |
| Protocol (for publication) | Protocol REDICaP_en_track | 3 |
| Protocol (for publication) | Protocollo REDICaP red | 3 |
| Protocol (for publication) | Protocollo REDICaP ITA_track | 3 |
| Protocol (for publication) | Protocollo REDICaP V 2 1 del 07 07 2025 clean RED | 2.1 |
| Protocol (for publication) | Protocollo REDICaP V2 1 del 07 07 2025 TC RED | 2.1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en REDICaP | 1 |
| Subject information and informed consent form (for publication) | Consenso al trattamento dei dati personali red | 2 |
| Subject information and informed consent form (for publication) | Consenso al trattamento dei dati personali V2 del 9 March 2026_track red | 2 |
| Subject information and informed consent form (for publication) | Consenso informato red | 2 |
| Subject information and informed consent form (for publication) | Consenso informato V2 del 9 March 2026_track red | 2 |
| Subject information and informed consent form (for publication) | Lett MMG REDI CaP | 2 |
| Subject information and informed consent form (for publication) | Lett MMG REDI CaP V2 del 9 March 2026_track | 2 |
| Subject information and informed consent form (for publication) | PROFFIT QUESTIONARIO | 1 |
| Subject information and informed consent form (for publication) | Questionario EORTC PR25 Italian | 1 |
| Subject information and informed consent form (for publication) | Questionario EORTC QLQ-C30 Italian | 1 |
| Subject information and informed consent form (for publication) | Questionario IIEF 5 | 1 |
| Subject information and informed consent form (for publication) | Questionario IPSS | 1 |
| Subject information and informed consent form (for publication) | REDICAP_Diario del Paziente v1 del 24 July 2025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Orgovyx II-24 | 1 |
| Synopsis of the protocol (for publication) | Sinossi ITA_track | 3 |
| Synopsis of the protocol (for publication) | Sinossi red | 3 |
| Synopsis of the protocol (for publication) | Synopsis eng red | 3 |
| Synopsis of the protocol (for publication) | Synopsis_track_en | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-15 | Italy | Acceptable 2025-07-14
|
2025-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-31 | Italy | Acceptable 2026-04-20
|
2026-05-13 |