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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario Quirón Madrid
  Pozuelo de Alarcón, Madrid, Spain 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 Universitario Fundación Jiménez Díaz
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Pablo Raña, PhD
• Email: investigacion@seor.es
• Phone: 0034696633409

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

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• Understanding how ADT for prostate cancer may raise blood pressure and whether nerves or kidneys are involved

  This study tests whether nervous system or kidney dysfunction contributes to high blood pressure in men receiving androgen deprivation therapy for prostate cancer.

  Recruiting Phase 4 Virginia Commonwealth University · Richmond, Virginia · NCT07848828

• Home-based telerehabilitation for rural men on hormone therapy for metastatic prostate cancer

  This trial tests whether a home telerehabilitation program helps men in rural areas receiving androgen deprivation therapy for metastatic prostate cancer feel and function better than home exercise without the technology.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07032584

• Combining salvage radiotherapy and androgen deprivation therapy with rezvilutamide for prostate cancer recurrence

  This study is testing if adding a new drug called rezvilutamide to hormone therapy and radiation can help men whose prostate cancer has come back after surgery.

  Recruiting at 2 sites Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu and 1 other locations · NCT06305832

• Using rezvilutamide for prostate cancer recurrence after surgery

  This study is testing if a new drug called rezvilutamide, used with hormone therapy and radiation, can help men whose prostate cancer has come back after surgery.

  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu and 1 other locations · NCT05753566

• Exercise program to improve heart health in Black men with prostate cancer on hormone therapy

  This study is testing whether a special exercise program can help improve heart health and overall well-being in Black men with prostate cancer who are receiving hormone therapy.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT05327465

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.