Trial Title:
Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624
NCT ID:
NCT05781217
Condition:
Prostate Cancer
Salvage Radiotherapy
Biochemical Recurrence
Androgen Deprivation Therapy
Metastases-free Survival
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Goserelin
Triptorelin Pamoate
Leuprolide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
triptorelin, goserelin, leuprorelin
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.
Arm group label:
long-term ADT (24 months)
Arm group label:
short-term ADT (6 months)
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Catalán de Oncología Hospitalet
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Anna Maria Boladeras, MD
Facility:
Name:
Hospital Universitario de Fuenlabrada
Address:
City:
Fuenlabrada
Zip:
28942
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario Quirón Madrid
Address:
City:
Pozuelo De Alarcón
Zip:
28223
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Victor Duque, MD
Facility:
Name:
Hospital de Cruces
Address:
City:
Baracaldo
Zip:
48903
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Alfonso Gómez, MD
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Xavier Maldonado, MD
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Joel Mases, MD
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Gemma Sancho, MD
Facility:
Name:
Hospital San Francisco de Asís
Address:
City:
Madrid
Zip:
28002
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Felipe Couñago, MD
Facility:
Name:
Hospital Gregorio Marañón
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Carmen González, MD
Facility:
Name:
Hospital Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Fernando López, MD
Facility:
Name:
Hospital Ruber Internacional
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Aurora Rodríguez, MD
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Noelia Sanmamed, MD
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jesús Oliveira, MD
Facility:
Name:
Hospital Universitario de La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Luis Alberto Glaria, MD
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario Sant Joan de Reus
Address:
City:
Tarragona
Zip:
43204
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario y Politécnico de La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Antonio José Conde, MD
Start date:
March 14, 2023
Completion date:
December 2032
Lead sponsor:
Agency:
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Agency class:
Other
Source:
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781217
