CTRI/2022/10/046239RecruitingPhase 2
PRostate Only radiotherapy versus radiotherapy to all Sites in Oligo-metastatic prostate cancer (PROS-O) - A phase II randomized open label study - PROS O
Intramural Tata memorial Centre0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Metastatic prostate cancer (Oligo-metastases i.e. metastases)
- •Patient must have 1-5 asymptomatic/ mildly symptomatic metastatic tumor(s) of the bone and soft tissue /liver/ lung/ lymph node developed that are amenable for SABR.
- •Patient must not have had their primary tumor treated with radiation.
- •Histologic confirmation of malignancy (primary or metastatic tumor).
- •Prostate specific antigen (PSA) ââ?°Â¥ 0.5 ng/mL
- •Hormone sensitive and castration resistant prostate cancer
- •PSMA PET not older than 2 months from randomization
- •Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer.
- •Patient must be ââ?°Â¥ 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
- •Patient must have an Eastern Cooperative Oncology Group performance status ââ?°Â¤ 2.
- •Patient must have normal organ and marrow function as defined as: Leukocytes >2,000/Ã?¼L, absolute neutrophil count >1,000/Ã?¼L, platelets >50,000/Ã?¼L
Exclusion Criteria
- •No more than 3 years of ADT is allowed
- •Spinal cord compression or impending spinal cord compression.
- •Suspected pulmonary and/or liver metastases not amenable for SABR
- •Receipt of any other investigational agents or participation in a concurrent treatment protocol
- •Large TURP defects
- •Moderate-severe urinary symptoms (e.g. high IPSS score, typically defined as IPSS > 20)
- •Excessive artefact not allowing proper localization of prostate e.g. Hip replacement
- •Serum creatinine and total bilirubin > 3 times the upper limit of normal
- •Liver Transaminases > 5-times the upper limit of normal or intractable ascites
- •Inability to lie flat during or tolerate PET/CT, PET/MRI or SABR.
- •Refusal to sign informed consent
Investigators
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