Clinical trial of androgen deprivation therapy combined with salvage radiotherapy when treating prostate cancer that has suffered recurrence after surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto De Investigacion En Oncología Radioterapica FEOR

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]

Trial duration

13 Mar 2023 → ongoing

Decision date (initial)

2024-11-08

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517666-41-00

EudraCT number

2021-006975-41

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy

Secondary objectives 8

1. To compare the two study arms in terms of the following variables: * Biochemical-relapse free interval
2. * Biochemical-relapse free interval
3. * Pelvic progression-free survival
4. * Time to start of cytotoxic treatment
5. * Time to castration resistance
6. * Cancer-specific survival
7. * Overall survival
8. * Acute and late toxicity

Conditions and MedDRA coding

Prostate Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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) (Protocol page 8)
4. Testosterone level > 150 ng/dL at inclusion
5. ECOG 0-1
6. Life expectancy > 5 years
7. Signed informed consent

Exclusion criteria 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion En Oncología Radioterapica FEOR

Sponsor organisation

Instituto De Investigacion En Oncología Radioterapica FEOR

Address

Calle Del Doctor Esquerdo 105

City

Madrid

Postcode

28007

Country

Spain

Scientific contact point

Organisation

Instituto De Investigacion En Oncología Radioterapica FEOR

Contact name

Pablo Raña

Public contact point

Organisation

Instituto De Investigacion En Oncología Radioterapica FEOR

Contact name

Pablo Raña

Locations

1 EU/EEA country · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications