Clinical trial • Phase III • Oncology|Other
Triptorelin for Prostate cancer
Phase III trial of Triptorelin for Prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-11-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
Randomised, short-term adt (6 months) versus long-term adt (24 months), both combined with salvage radiotherapy; permitted adt medications listed include decapeptyl semestral 22.5 mg (triptorelin), zoladex 3.6 mg implant (goserelin acetate), eligard semestral 45 mg (leuprorelin acetate); bicalutamida aristo 50 mg is included as an auxiliary product.-controlled Phase III trial across 19 sites in Spain.
- Randomised
- Yes
- Comparator
- Short-term ADT (6 months) versus long-term ADT (24 months), both combined with salvage radiotherapy; permitted ADT medications listed include Decapeptyl semestral 22.5 mg (triptorelin), Zoladex 3.6 mg implant (goserelin acetate), Eligard semestral 45 mg (leuprorelin acetate); Bicalutamida Aristo 50 mg is included as an auxiliary product.
- Target Sample Size
- 534
- Trial Duration For Participant
- 1825
Eligibility
Recruits 534 No vulnerable populations selected. Signed informed consent is required; inability to understand the treatment protocol or sign informed consent is an exclusion criterion..
- Vulnerable Population
- No vulnerable populations selected. Signed informed consent is required; inability to understand the treatment protocol or sign informed consent is an exclusion criterion.
Inclusion criteria
- {"criterion_text":"- Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion\n- Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng/mL; however, in patients with PSA > 0.4 ng/mL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET/CT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng/mL, no further tests are required to check for distant metastases prior to inclusion.\n- Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18) (Protocol page 8)\n- Testosterone level > 150 ng/dL at inclusion\n- ECOG 0-1\n- Life expectancy > 5 years\n- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Presence of pN1 disease in the original surgical specimen\n- Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is > 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body magnetic resonance imaging [MRI]) are required\n- PSA <0.2 or <0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).\n- Previous pelvic radiotherapy\n- Radiotherapy contraindicated\n- Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)\n- Inability to understand the treatment protocol or sign informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy","definition_or_measurement_approach":"Comparison of 5-year distant metastasis-free survival (MFS) rates between long-term (24 months) and short-term (6 months) ADT arms in patients receiving salvage radiotherapy."}
Recruitment
- Planned Sample Size
- 534
- Recruitment Window Months
- 36
- Consent Approach
- Signed informed consent required from participants. A subject information and informed consent form for adults (L1_SIS-ICF adults v7-1) is provided. No paediatric/assent documents or minors mentioned.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 534
Spain
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 442
- Number Of Sites
- 19
- Number Of Participants
- 534
Sites
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Patricia Willisch Santamaria
- Principal Investigator Email
- patriciawillisch@gmail.com
- Contact Person Name
- Patricia Willisch Santamaria
- Contact Person Email
- patriciawillisch@gmail.com
- Site Name
- University Hospital Son Espases
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Araceli Guerrero Grande
- Principal Investigator Email
- araceli.guerrero@ssib.es
- Contact Person Name
- Araceli Guerrero Grande
- Contact Person Email
- araceli.guerrero@ssib.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Joel Mases Rosinés
- Principal Investigator Email
- MASES@clinic.cat
- Contact Person Name
- Joel Mases Rosinés
- Contact Person Email
- MASES@clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Jesus Olivera Vegas
- Principal Investigator Email
- JOlivera@fjd.es
- Contact Person Name
- Jesus Olivera Vegas
- Contact Person Email
- JOlivera@fjd.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Jeannette Valero Albarrán
- Principal Investigator Email
- jvalero@hmhospitales.com
- Contact Person Name
- Jeannette Valero Albarrán
- Contact Person Email
- jvalero@hmhospitales.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Sandra Fernandez Alonso
- Principal Investigator Email
- sfalonso@salud.madrid.org
- Contact Person Name
- Sandra Fernandez Alonso
- Contact Person Email
- sfalonso@salud.madrid.org
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Luis Alberto Glaria Enríquez
- Principal Investigator Email
- glaria_2864@icloud.com
- Contact Person Name
- Luis Alberto Glaria Enríquez
- Contact Person Email
- glaria_2864@icloud.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Antonio Jose Conde Moreno
- Principal Investigator Email
- conde_ant@gva.es
- Contact Person Name
- Antonio Jose Conde Moreno
- Contact Person Email
- conde_ant@gva.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Fernando Lopez Campos
- Principal Investigator Email
- flcampos@salud.madrid.org
- Contact Person Name
- Fernando Lopez Campos
- Contact Person Email
- flcampos@salud.madrid.org
- Site Name
- Hospital Ruber Internacional
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Aurora Rodríguez Pérez
- Principal Investigator Email
- arodriguez@ruberinternacional.es
- Contact Person Name
- Aurora Rodríguez Pérez
- Contact Person Email
- arodriguez@ruberinternacional.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Ana Maria Boladeras Inglada
- Principal Investigator Email
- aboladeras@iconcologia.net
- Contact Person Name
- Ana Maria Boladeras Inglada
- Contact Person Email
- aboladeras@iconcologia.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Gemma Sancho Pardo
- Principal Investigator Email
- GSancho@santpau.cat
- Contact Person Name
- Gemma Sancho Pardo
- Contact Person Email
- GSancho@santpau.cat
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Alfonso Gómez de Iturriaga
- Principal Investigator Email
- agomeziturriaga@gmail.com
- Contact Person Name
- Alfonso Gómez de Iturriaga
- Contact Person Email
- agomeziturriaga@gmail.com
- Site Name
- Salut Sant Joan De Reus
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Ivan Henriquez López
- Principal Investigator Email
- ivanhenriquezlopez@me.com
- Contact Person Name
- Ivan Henriquez López
- Contact Person Email
- ivanhenriquezlopez@me.com
- Site Name
- Hospital Universitario San Francisco de Asís
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Felipe Couñago Lorenzo
- Principal Investigator Email
- fcounago@gmail.com
- Contact Person Name
- Felipe Couñago Lorenzo
- Contact Person Email
- fcounago@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Xavier Maldonado Pijoan
- Principal Investigator Email
- xavier.maldonado@vallhebron.cat
- Contact Person Name
- Xavier Maldonado Pijoan
- Contact Person Email
- xavier.maldonado@vallhebron.cat
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Ángel Calvo Tudela
- Principal Investigator Email
- angelcaltu@gmail.com
- Contact Person Name
- Ángel Calvo Tudela
- Contact Person Email
- angelcaltu@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Carmen González Sansegundo
- Principal Investigator Email
- cglezss@gmail.com
- Contact Person Name
- Carmen González Sansegundo
- Contact Person Email
- cglezss@gmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncología Radioterápica
- Principal Investigator Name
- Victor Duque Santana
- Principal Investigator Email
- victorduquesantana@gmail.com
- Contact Person Name
- Victor Duque Santana
- Contact Person Email
- victorduquesantana@gmail.com
Sponsor
Primary sponsor
- Full Name
- Instituto De Investigacion En Oncología Radioterapica FEOR
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Decapeptyl semestral 22,5 mg polvo y disolvente para suspensión de liberación prolongada inyectable.
- Active Substance
- Triptorelin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised
- Frequency
- Every 6 months (semestral)
- Maximum Dose
- 22.5 mg
- Investigational Product Name
- Zoladex 3,6 mg implante en jeringa precargada
- Active Substance
- Goserelin acetate
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Maximum Dose
- 3.6 mg
- Investigational Product Name
- Eligard semestral 45 mg polvo y disolvente para solución inyectable.
- Active Substance
- Leuprorelin acetate
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised
- Frequency
- Every 6 months (semestral)
- Maximum Dose
- 45 mg
- Combination Treatment
- Yes
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