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

NCT05781217 | Recruiting Phase 3 DMC

• 1 other identifier: URONCOR 06-24
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• 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 (this same starting point applies to all secondary objectives) until the patient develops M1a disease (involved retroperitoneal lymph nodes) or M1b-c disease (bone/visceral involvement) according to RECIST 1.1 criteria based on conventional computed tomography (CT) imaging and bone scans. The use of advanced molecular imaging-PSMA or choline positron-emission tomography (PET)/CT-is subject to the centre-specific protocols in place at the participating hospitals; however, metastatic progression will be determined according to RECIST 1.1 criteria based on conventional imaging tests.

  5 years

Secondary Outcomes (9)

• To compare the two study arms in terms of the Biochemical-relapse free interval

  5 years

• To compare the two study arms in terms of the Pelvic progression-free survival

  5 years

• To compare the two study arms in terms of the Time to start of cytotoxic treatment

  5 years

• To compare the two study arms in terms of the Time to castration resistance

  5 years

• To compare the two study arms in terms of the Cancer-specific survival

  5 years

Study Arms (2)

short-term ADT (6 months)

ACTIVE COMPARATOR

ARM 1: LHRH analogues for 6 months + bicalutamide 50 for 30 days

Drug: triptorelin, goserelin, leuprorelin

long-term ADT (24 months)

ACTIVE COMPARATOR

LHRH analogues for 24 months + bicalutamide 50 for 30 days

Drug: triptorelin, goserelin, leuprorelin

Interventions

triptorelin, goserelin, leuprorelin 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); short-term ADT (6 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG 0-1
• Life expectancy \> 5 years
• Signed informed consent

You may not qualify if:

• Presence of pN1 disease in the original surgical specimen
• 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.
• PSA \<0.2 or \<0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).
• Previous pelvic radiotherapy
• Radiotherapy contraindicated
• Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)
• Inability to understand the treatment protocol or sign informed consent

Sponsors & Collaborators

• Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic: lead

Study Sites (17)

Instituto Catalán de Oncología Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

NOT YET RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

NOT YET RECRUITING

Hospital San Francisco de Asís

Madrid, 28002, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Ruber Internacional

Madrid, 28034, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario de La Paz

Madrid, 28046, Spain

NOT YET RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Sant Joan de Reus

Tarragona, 43204, Spain

ACTIVE NOT RECRUITING

Hospital Universitario y Politécnico de La Fe

Valencia, 46026, Spain

NOT YET RECRUITING

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Goserelin; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Pablo Raña, PhD

CONTACT

0034696633409; investigacion@seor.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 23, 2023
• Study Start: March 14, 2023
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ES (17)