Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

NCT ID: NCT05781217

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2032-12-31

Brief Summary

The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score > 7, stage pT3-T4, PSA > 1 ng/mL in cases with biochemical recurrence [BCR], and PSA doubling time [PSA-DT] < 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels > 1 ng/mL at recurrence.

The results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT.

In line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial.

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short-term ADT (6 months)

ARM 1:

LHRH analogues for 6 months + bicalutamide 50 for 30 days

Group Type: ACTIVE_COMPARATOR

triptorelin, goserelin, leuprorelin

Intervention Type: DRUG

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.

long-term ADT (24 months)

LHRH analogues for 24 months + bicalutamide 50 for 30 days

Group Type: ACTIVE_COMPARATOR

triptorelin, goserelin, leuprorelin

Intervention Type: DRUG

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.

Interventions

triptorelin, goserelin, leuprorelin

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.

Intervention Type: DRUG

Eligibility Criteria

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 (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.

3. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):

CHARACTERISTICS INTERMEDIATE RISK (≥ 2) HIGH RISK(≥ 1)

PSA at diagnosis, ng/mL 0.6-1.0 ≥1.0 PSA doubling time, months 6-12 < 6 GLEASON / ISUP 7/3 ≥8/≥4 TNM (prostatectomy specimen) pT2-3a pN0-Mx pT3b pN0-Mx Time to biochemical recurrence, months >18 <18 Margins Positive Positive

4. Testosterone level > 150 ng/dL at inclusion

5. ECOG 0-1

6. Life expectancy > 5 years

7. Signed informed consent

Exclusion Criteria

1. Presence of pN1 disease in the original surgical specimen

2. 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.

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 (e.g., finasteride, dutasteride, high dose steroids)

7. Inability to understand the treatment protocol or sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Catalán de Oncología Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Site Status: ACTIVE_NOT_RECRUITING

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status: RECRUITING

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Hospital San Francisco de Asís

Madrid, , Spain

Site Status: RECRUITING

Hospital Gregorio Marañón

Madrid, , Spain

Site Status: RECRUITING

Hospital Ramón y Cajal

Madrid, , Spain

Site Status: RECRUITING

Hospital Ruber Internacional

Madrid, , Spain

Site Status: RECRUITING

Hospital Clínico San Carlos

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario de La Paz

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Hospital Universitario Sant Joan de Reus

Tarragona, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Hospital Universitario y Politécnico de La Fe

Valencia, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Pablo Raña, PhD

Role: CONTACT

investigacion@seor.es

0034696633409

Facility Contacts

Anna Maria Boladeras, MD

Role: primary

Victor Duque, MD

Role: primary

Alfonso Gómez, MD

Role: primary

Xavier Maldonado, MD

Role: primary

Joel Mases, MD

Role: primary

Gemma Sancho, MD

Role: primary

Felipe Couñago, MD

Role: primary

Carmen González, MD

Role: primary

Fernando López, MD

Role: primary

Aurora Rodríguez, MD

Role: primary

Noelia Sanmamed, MD

Role: primary

Jesús Oliveira, MD

Role: primary

Luis Alberto Glaria, MD

Role: primary

Antonio José Conde, MD

Role: primary

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Other Identifiers

URONCOR 06-24

Identifier Type: -

Identifier Source: org_study_id