Comparing two treatments for prostate cancer recurrence after surgery

A Phase II Study Comparing Salvage Radiotherapy in Combination With 6 Months of Androgen-deprivation Therapy Versus Anti-androgen Therapy With Apalutamide in Patients With Biochemical Progression After Radical Prostatectomy

This study is testing if combining salvage radiotherapy with either hormone therapy or a different anti-androgen treatment can help men with prostate cancer recurrence after surgery while looking at how these options affect sexual function.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Cancer Research Antwerp (Academic / other)
• Drugs / interventions: radiation
• Locations: 9 sites (Aalst and 8 other locations)
• Trial ID: NCT03899077 on ClinicalTrials.gov

What this trial studies

This phase II randomized, open-label study evaluates the effectiveness of salvage radiotherapy combined with either androgen-deprivation therapy (ADT) using LHRH agonists or antagonists, or anti-androgen therapy (AAT) with apalutamide in hormone-naïve patients who have experienced biochemical progression after radical prostatectomy. Participants will receive standard salvage radiotherapy and will be randomly assigned to one of the two treatment arms for a duration of six months. The primary objective is to assess sexual function differences between the two groups using the EPIC-26 sexual domain scores at nine months post-treatment initiation. The study aims to explore alternatives to traditional ADT, which can have significant side effects.

Who should consider this trial

Good fit: Ideal candidates are male patients over 18 years old with hormone-naïve prostate cancer who have undergone radical prostatectomy and show biochemical progression.

Not a fit: Patients with advanced prostate cancer or those who have previously received hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less harmful treatment option for patients with prostate cancer recurrence, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown success with similar approaches, particularly in combining salvage radiotherapy with ADT, indicating potential for this novel comparison.

Eligibility criteria

Inclusion Criteria:

1. Male, \> 18 years old.
2. ECOG 0-1.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Previous radical prostatectomy (RP), pT2-3, pN0 or pNx.
5. PSA detectable with confirmed rise (at least 2 weeks apart) at least 8 weeks after RP.
6. Hormone-naive disease.
7. Patients amendable to take oral medication.
8. Patients must have clinical laboratory values at screening:

   1. Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
   2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
   3. Serum albumin ≥3.0 g/dL
   4. Serum creatinine \<2.0 × upper limit of normal (ULN)
   5. Serum potassium ≥3.5 mmol/L
   6. Serum total bilirubin 1.5 × ULN (note: in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
   7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN
9. Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry.
10. Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
11. Patients who have received the information sheet and signed the informed consent form.
12. Patients must be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7).
2. Allergies, hypersensitivity or known intolerance to the study drugs or excipients.
3. History of any of the following:

   1. Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
   2. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization.
4. Current evidence of any of the following:

   1. Uncontrolled hypertension.
   2. Gastrointestinal disorder affecting absorption.
5. Patients already included in another clinical trial involving an experimental drug.

Where this trial is running

Aalst and 8 other locations

• OLVZ Aalst — Aalst, Belgium (Recruiting)
• AZ Sint-Jan — Brugge, Belgium (Recruiting)
• Hopital Erasme — Bruxelles, Belgium (Recruiting)
• UZ Gent — Gent, Belgium (Recruiting)
• CH Jolimont — Haine-Saint-Paul, Belgium (Active_not_recruiting)
• UZ Brussel — Jette, Belgium (Active_not_recruiting)
• AZ Groeninge — Kortrijk, Belgium (Recruiting)
• CHU UCL Namur — Namur, Belgium (Active_not_recruiting)
• Gza — Wilrijk, Belgium (Recruiting)

Study contacts

• Principal investigator: Piet Dirix — Gasthuis Zusters Antwerpen
• Study coordinator: Ilse Van der Auwera

Conditions Cancer of Prostate