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 : Recruiting
First Posted : April 2, 2019
Last Update Posted : January 27, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 5, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||September 2022|
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).
Apalutamide 240mg daily for 6 months (i.e. 6 28-day cycles); oral use
- 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)
- 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.
- 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.
- 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.
- 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)
- 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.
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
|Contact: Ilse Van der Auwerafirstname.lastname@example.org|
|Contact: Nele Smetemail@example.com|
|Principal Investigator:||Piet Dirix||Gasthuis Zusters Antwerpen|