Adding Short-Term Androgen Deprivation and Hormone Therapy to Metastasis-Directed Treatment for Oligorecurrent Hormone Sensitive Prostate Cancer to Improve Survival
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
873
Participants Needed
1
Research Sites
261 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether adding short-term androgen deprivation therapy ADT for either 1 month or 6 months, combined with an androgen receptor targeted therapy ARTA, to metastasis-directed therapy MDT can significantly extend the time patients with oligorecurrent hormone sensitive prostate cancer remain free from widespread metastases or metastatic castration-resistant prostate cancer. This phase 3 clinical trial explores improving outcomes by combining systemic treatments with targeted therapies in men whose cancer has returned but remains hormone sensitive.
The study compares three treatment groups MDT alone, MDT plus 1 month of ADT using drugs such as gosereline, leuproreline, or triptoreline, and MDT plus 6 months of ADT combined with the ARTA drug enzalutamide. MDT involves stereotactic body radiotherapy SBRT or surgery to target metastatic lesions. Participants receive these treatments according to their assigned group, with dosing schedules including monthly or quarterly injections of ADT drugs and daily oral enzalutamide during the 6-month period.
Participants will be involved in the study for up to 10 years, with follow-up assessments up to 5 years for outcomes like poly-metastatic free survival, metastatic castration-resistant prostate cancer free survival, biochemical and clinical progression-free survival, quality of life, and treatment toxicity. Researchers will monitor these outcomes alongside overall and cancer-specific survival to evaluate the long-term benefits and safety of adding systemic therapy to MDT in this patient group.
CONDITIONS
Brief Title
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
Research Team
K
Kato Rans, MD
G
Gert De Meerleer, MD, PhD
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Histologically proven initial diagnosis of prostate adenocarcinoma
Primary tumor previously treated and controlled
Biochemical recurrence with PSA >0.2 ng/ml following radical prostatectomy and/or high-dose radiotherapy
Oligorecurrent disease with a maximum of 5 extracranial metastases diagnosed on PSMA PET-CT or PET-MRI
Nodal disease included only with M1a-c disease and total lesions not exceeding 5
Serum testosterone level within normal range
WHO performance status 0-2
Age 18 years or older
No psychological, sociological, or geographical conditions affecting study compliance
Approval by multidisciplinary board meeting
Voluntary written informed consent obtained
Use of highly effective birth control methods during the trial period
You will not qualify if you...
Any disorder compromising participant safety or study compliance
Prior or concurrent treatments jeopardizing safety or trial integrity
Participation in another interventional trial with investigational drugs or devices
Serum testosterone at castration level
PSA rise while on active hormonal treatment
Presence of more than 5 metastatic lesions (poly-metastatic disease)
Active malignancies other than prostate cancer affecting study interpretation
Previous treatments or comorbidities preventing new stereotactic body radiotherapy
Contraindications to enzalutamide such as seizure risk or recent significant cardiovascular events
Inability to understand treatment protocol or provide informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Metastasis-directed therapy
Duration - Up to 1 month
Participants receive treatment targeting metastatic lesions using stereotactic body radiotherapy (SBRT) and/or surgery (metastasectomy).
1 to 2 visits depending on treatment type
Androgen deprivation therapy (ADT) and Androgen receptor targeted therapy (ARTA)
Duration - 1 month or 6 months depending on treatment arm
Participants in experimental arms receive short-term ADT for either 1 month or 6 months, with the 6-month group also receiving enzalutamide daily during this period.
Monthly visits corresponding to ADT administration
Follow-up
Duration - Up to 10 years after metastasis-directed therapy
Participants are monitored for poly-metastatic free survival, castration-refractory prostate cancer free survival, progression-free survival, toxicity, quality of life, and overall survival.
Regular visits as scheduled over several years for ongoing monitoring
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival?