A trial comparing chemical castration (reducing production of male hormone) versus direct cancer targeting through the male hormone receptor in combination with local radiotherapy for prostate cancer patients who progress after surgery
- Conditions
- Prostate cancer patients with biochemical progression after radical prostatectomy and planned for salvage radiotherapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004365-13-BE
- Lead Sponsor
- GZA vzw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 202
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 two 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:
a) Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
b) Platelet count =100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization c) Serum albumin =3.0 g/dL
d) Serum creatinine <2.0 × upper limit of normal (ULN)
e) Serum potassium =3.5 mmol/L
f) 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) g) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
9. Medications known to lower the seizure threshold (see list under prohibited meds, see appendix E of the protocol) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 101
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 101
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:
a) 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).
b) 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:
a) Uncontrolled hypertension.
b) Gastrointestinal disorder affecting absorption.
5. Patients already included in another clinical trial involving an experimental drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate AAT with apalutamide as a sexual function-sparing alternative to ADT with LHRH agonist or antagonist <br>;Secondary Objective: - to assess general quality of life <br>- to evaluate safety <br>- to evaluate efficacy ;Primary end point(s): EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function) ;Timepoint(s) of evaluation of this end point: 9 months after start of treatment <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Quality of life (quality of life will be assessed using EPIC-26 as well as the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and PR25 as well as FACT-P, see appendix B, C and D of the protocol); 2. Toxicity; and 3. Efficacy (i.e. prostate-specific antigen (PSA) response rates, defined as a decline from baseline in PSA level of 80% or greater, as well as PSA complete response rates, defined as a decline from baseline in PSA level of 90% or greater <br>;Timepoint(s) of evaluation of this end point: At all 4 treatment visits (i.e. at 0, 3, 6, and 9 months) <br>