Study record

Short title	Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624
Official title	Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy: a Multicentre Phase III Randomised Controlled Trial
Acronym	URONCOR 06-24
ClinicalTrials.gov ID	NCT05781217
Status	Recruiting
Fase	Phase 3
Study type	Interventional
Estimated participants	534

Promotor

Sponsor	Research Institute in Radiation Oncology – Spanish Foundation of Radiation Oncology
Last registry update	November 17, 2023

Study contact

Nombre	Telephone	Email
Pablo Raña, PhD	0034696633409	investigacion@seor.es

Equipo investigador

Rol	Nombre
Investigador principal	Felipe Couñago
Co-investigadora principal	Carmen González San Segundo
Co-investigador principal	Alfonso Gómez Iturriaga
Co-investigador principal	Fernando López Campos

Condiciones

• Prostate Cancer
• Biochemical Recurrence
• Androgen Deprivation Therapy
• Salvage Radiotherapy
• Metastases-free Survival

Intervention / treatment

Tipo	Intervention / treatment	Description
Drug	Triptorelin, goserelin, leuprorelin	ADT with LHRH analogues, with bicalutamide 50 mg/day started 10 days before the first ADT injection and discontinued after 30 days.

Study design

Primary Purpose	Treatment
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Number of arms	2

Study arms

Brazo	Tipo	Treatment
Short-term ADT (6 months)	Active Comparator	LHRH analogues for 6 months + bicalutamide 50 for 30 days.
Long-term ADT (24 months)	Active Comparator	LHRH analogues for 24 months + bicalutamide 50 for 30 days.

Treatment description

ADT will consist of LHRH analogues (triptorelin, goserelin, leuprorelin) with bicalutamide 50 mg/day started 10 days before the first ADT injection to avoid LHRH-related flare-ups. Bicalutamide will be discontinued after 30 days. The LHRH analogue will be initiated prior to the start of radiotherapy and administered for 6 or 24 months depending on treatment allocation. The maximum time permitted between randomisation and administration of the first LHRH dose is 30 days. The maximum time from the first LHRH dose to the start of SRT is 60 days.

Study summary

SRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, the study intends to perform a multicentre, phase III trial to define the optimal duration of ADT: 6 vs. 24 months.

Primary outcome measure

Outcome Measure	Measure Description	Time Frame
To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy	Distant metastasis-free survival: time from administration of the first LHRH analogue until the patient develops M1a disease or M1b-c disease according to RECIST 1.1 criteria based on conventional CT imaging and bone scans.	5 years

Secondary outcome measures

Outcome Measure	Measure Description	Time Frame
Biochemical-relapse free interval	BRFS: time to biochemical progression defined as an increase in PSA confirmed by a second PSA determination.	5 years
Pelvic progression-free survival	Pelvic PFS: time to local recurrence and/or N1 disease according to RECIST 1.1 criteria by conventional CT imaging and bone scan.	5 years
Time to start of cytotoxic treatment	Cytotoxic treatment-free interval: time to the start of the first cytotoxic treatment or local treatment for oligorecurrence.	5 years
Time to castration resistance	Time to biochemical and/or clinical progression with castration levels.	5 years
Cancer-specific survival	Time to death due to prostate cancer or treatment-related complications.	5 years
Overall survival	Time to death from any cause.	5 years
Acute and late toxicity	Acute toxicity according to CTCAE criteria v. 4.0.	5 years
Late toxicity	Late toxicity from 3 months to 5 years after completing RT according to CTCAE v. 4.0.	5 years
Quality of life (QoL)	Assessed with the EORTC QLQ-C30 and QLQ-PR25 questionnaires.	5 years

Participation criteria

Edad	18 years and older
Voluntarios sanos	No

Inclusion criteria

1. Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.
2. 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.
3. Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng/mL.
4. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al.
5. Testosterone level > 150 ng/dL at inclusion.
6. ECOG 0-1.
7. Life expectancy > 5 years.
8. Signed informed consent.

Exclusion criteria

1. Presence of pN1 disease in the original surgical specimen.
2. Presence of macroscopic disease on imaging tests.
3. PSA < 0.2 or < 0.15 ng/mL if Gleason score = 10, pT3b, or R1 in the radical prostatectomy specimen.
4. Previous pelvic radiotherapy.
5. Radiotherapy contraindicated.
6. Ongoing treatment with ADT or PSA-modulating drugs.
7. Inability to understand the treatment protocol or sign informed consent.

Study sites

Ciudad	Status	Centre	Contacto
Barcelona, Spain, 08036	Not yet recruiting	Hospital Clinic De Barcelona	Joel Mases, MD
Barcelona, Spain, 08035	Not yet recruiting	Hospital Universitario Vall d’Hebron	Xavier Maldonado, MD
Barcelona, Spain, 08041	Not yet recruiting	Hospital De La Santa Creu I Sant Pau	Gemma Sancho, MD
Madrid, Spain, 28034	Recruiting	Hospital Ramon y Cajal	Fernando López, MD
Madrid, Spain, 28040	Recruiting	Hospital Universitario Fundacion Jimenez Diaz	Jesús Oliveira, MD
Madrid, Spain, 28040	Not yet recruiting	Hospital Clinico San Carlos	Noelia Sanmamed, MD
Madrid, Spain, 28034	Recruiting	Hospital Ruber Internacional	Aurora Rodríguez, MD
Madrid, Spain, 28007	Recruiting	Hospital Gregorio Marañón	Carmen González, MD
Madrid, Spain, 28050	Active, not recruiting	Hospital Universitario HM Sanchinarro
Madrid, Spain, 28002	Recruiting	Hospital San Francisco de Asís	Felipe Couñago, MD
Madrid, Spain, 28046	Not yet recruiting	Hospital Universitario de la Paz	Luis Alberto Glaria, MD
Tarragona, Spain, 43204	Active, not recruiting	Hospital Universitario Sant Joan de Reus
Valencia, Spain, 46026	Not yet recruiting	Hospital Universitario y Politecnico de La Fe	Antonio José Conde, MD
L’Hospitalet de Llobregat, Barcelona, Spain, 08908	Not yet recruiting	Instituto Catalán de Oncología Hospitalet	Anna Maria Boladeras, MD
Fuenlabrada, Madrid, Spain, 28942	Active, not recruiting	Hospital Universitario de Fuenlabrada
Pozuelo De Alarcón, Madrid, Spain, 28223	Recruiting	Hospital Universitario Quiron Madrid	Victor Duque, MD
Baracaldo, Vizcaya, Spain, 48903	Not yet recruiting	Hospital de Cruces	Alfonso Gómez, MD

More information

View official record on ClinicalTrials.gov