Comparing short and long-term hormone therapy with radiation for prostate cancer

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

This study tests whether short-term or long-term hormone therapy combined with radiation is better for men with prostate cancer who have had a recurrence after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic (Academic / other)
• Locations: 17 sites (L'Hospitalet de Llobregat, Barcelona and 16 other locations)
• Trial ID: NCT05781217 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of short versus long-term androgen deprivation therapy (ADT) combined with salvage radiotherapy in patients with prostate cancer who have experienced biochemical recurrence after radical prostatectomy. The study aims to clarify the optimal duration of ADT in conjunction with radiotherapy, addressing a longstanding debate in clinical practice. Patients will be monitored for biochemical relapse-free survival, particularly focusing on those with adverse prognostic factors. The trial includes various interventions such as triptorelin, goserelin, and leuprorelin.

Who should consider this trial

Good fit: Ideal candidates include men with histologically-confirmed prostate cancer who have undergone radical prostatectomy and are experiencing biochemical recurrence.

Not a fit: Patients with low-risk prostate cancer or those who have not undergone radical prostatectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines on the optimal duration of hormone therapy, potentially improving outcomes for prostate cancer patients.

How similar studies have performed: Previous studies have shown varying success with similar approaches, but this trial aims to provide more definitive evidence on the duration of ADT in conjunction with radiotherapy.

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

Where this trial is running

L'Hospitalet de Llobregat, Barcelona and 16 other locations

• Instituto Catalán de Oncología Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain (Not_yet_recruiting)
• Hospital Universitario de Fuenlabrada — Fuenlabrada, Madrid, Spain (Active_not_recruiting)
• Hospital Universitario Quirón Madrid — Pozuelo de Alarcón, Madrid, Spain (Recruiting)
• Hospital de Cruces — Barakaldo, Vizcaya, Spain (Not_yet_recruiting)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
• Hospital Clinic de Barcelona — Barcelona, Spain (Not_yet_recruiting)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Not_yet_recruiting)
• Hospital San Francisco de Asís — Madrid, Spain (Recruiting)
• Hospital Gregorio Marañón — Madrid, Spain (Recruiting)
• Hospital Ramón y Cajal — Madrid, Spain (Recruiting)
• Hospital Ruber Internacional — Madrid, Spain (Recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Not_yet_recruiting)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
• Hospital Universitario de La Paz — Madrid, Spain (Not_yet_recruiting)
• Hospital Universitario HM Sanchinarro — Madrid, Spain (Active_not_recruiting)
• Hospital Universitario Sant Joan de Reus — Tarragona, Spain (Active_not_recruiting)
• Hospital Universitario y Politécnico de La Fe — Valencia, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Pablo Raña, PhD

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