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Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (SAVE)

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ClinicalTrials.gov Identifier: NCT03899077
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Janssen Pharmaceutica
Information provided by (Responsible Party):
Cancer Research Antwerp

Brief Summary:
This is a phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist (arm A) versus anti-androgen therapy (AAT) with apalutamide 240mg daily (arm B) in hormone-naïve patients with biochemical progression after radical prostatectomy. All subjects will receive salvage radiotherapy as standard of care and will be randomly assigned in a 1:1 ratio to receive either 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist through 6 monthly, two 3-monthly or one 6-monthly injections (control arm) or 6 28-day cycles of apalutamide 240mg daily (interventional arm). The study will include a screening phase, treatment phase, and a post-treatment phase. The primary objective of the trial is to compare sexual function between the 2 groups based on the Expanded Prostate cancer Index Composite (EPIC)-26 sexual domain scores at 9 months after start of hormonal treatment.

Condition or disease Intervention/treatment Phase
Cancer of Prostate Drug: Apalutamide Drug: Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial Drug: Goserelin Acetate 10.8 MG Subcutaneous Implant Drug: Triptorelin Pamoate Drug: Degarelix acetate Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Comparing Salvage Radiotherapy in Combination With 6 Months of Androgen-deprivation Therapy Versus Anti-adrogen Therapy With Apalutamide in Patients With Biochemical Progression After Radical Prostatectomy
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Apalutamide

Arm Intervention/treatment
Active Comparator: Arm A
The standard hormonal treatment in combination with salvage radiotherapy is ADT by a LHRH agonist or antagonist for 24 weeks. LHRH agonists and antagonists include leuprolide, goserelin, triptorelin, and degarelix.
Drug: Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial
Leuprorelin acetate 45mg for 6 months; subcutaneous use

Drug: Goserelin Acetate 10.8 MG Subcutaneous Implant
Goserelin acetate 10.8mg for 6 months; subcutaneous use

Drug: Triptorelin Pamoate
Triptorelin pamoate 22.5mg for 6 months; intramuscular use

Drug: Degarelix acetate
Degarelix acetate 80mg for 6 months; subcutaneous use

Experimental: Arm B
Patients will receive 6 cycles (each cycle is 30 days) of the study drug (4x 60mg tablets daily in a single intake).
Drug: Apalutamide
Apalutamide 240mg daily for 6 months (i.e. 6 28-day cycles); oral use




Primary Outcome Measures :
  1. EPIC-26 sexual domain score [ Time Frame: 9 months after start of hormonal treatment ]
    EPIC-26 sexual domain score (0 - 100 scale, with higher scores representing better sexual function)


Secondary Outcome Measures :
  1. FACT-P quality of life global score [ Time Frame: 9 months after start of hormonal treatment ]
    Health related quality of life (QoL) will be assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire designed for patients with prostate cancer. It consists of 27 core items which assess patient function in four domains: physical, social/family, emotional, and functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. Higher scores represent better QoL.

  2. EORTC QLQ C30 quality of life score [ Time Frame: 9 months after start of hormonal treatment ]
    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30. The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single- item measures. These include five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.

  3. EORTC QLQ PR25 quality of life score [ Time Frame: 9 months after start of hormonal treatment ]
    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) PR25. scale. The EORTC QLQ-PR25 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to prostate cancer.

  4. Grade of acute toxicity [ Time Frame: After obtaining informed consent and up to 30 days after last dose ]
    Acute as well as late toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (published November 27, 2017)

  5. PSA response rates [ Time Frame: 0, 3, 6, and 9 months ]
    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, will be prospectively collected at 0, 3, 6, and 9 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 > 0,1 µg/L 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899077


Contacts
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Contact: Ilse Van der Auwera 003234433759 ilse.vanderauwera@gza.be
Contact: Nele Smet 003234433759 nele.smet@gza.be

Sponsors and Collaborators
Cancer Research Antwerp
Janssen Pharmaceutica
Investigators
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Principal Investigator: Piet Dirix Gasthuis Zusters Antwerpen

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Responsible Party: Cancer Research Antwerp
ClinicalTrials.gov Identifier: NCT03899077     History of Changes
Other Study ID Numbers: CTOR18001GZA
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Triptorelin Pamoate
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents