ACTRN12615001183572
Active, not recruiting
Phase 2
Phase II trial in men with rising PSA post-prostatectomy, harnessing PSMA-PET to identify local recurrence only and implanted Calypso real-time tracking beacons to measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent prostate cancer
- Sponsor
- Icon Cancer Foundation
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phase I (PSMA PET/CT)
- •\- Males age 18 years or older.
- •\- Patients who have undergone radical prostatectomy for histologically confirmed clinical stage T1\- T3 invasive prostate adenocarcinoma.
- •\- Post\-operative PSA 0\.1\-2\.5ng/ml.
- •\- No contraindications to undergoing 68Ga\-PSMA\-ligand PET/CT (including severe claustrophobia).
- •\- ECOG Status 0\-2
- •\- Able to undergo intensity modulated radiotherapy.
- •\- Patients or their legal representatives must have the ability to read, understand and provide written informed consent.
- •\- Able to participate in the stipulated follow\-up (either telephone follow\-up or on\-site visits acceptable, but one follow\-up annually should be in person).
- •\- Participants capable of child\-bearing are using adequate contraception.
Exclusion Criteria
- •\- Prostate cancer with significant sarcomatoid, ductal, spindle cell or neuroendocrine small cell components.
- •\- Evidence of secondary disease outside the prostate bed.
- •\- Previous radiotherapy treatment to the pelvis.
- •\- Any other active malignancy (untreated, progressive or recurrent), except for non\-melanoma skin cancer.
- •\- Any inactive malignancy diagnosed within 5 years of entry, except for non\-melanoma skin cancer.
- •\- Inflammatory bowel disease (active) such as Crohn’s disease and ulcerative colitis.
- •\- Haemorrhagic cystitis.
- •\- Known hypersensitivity to 68Ga, PSMA or any of the excipients of 68Ga\-PSMA.
- •\- Insufficient renal function (eGFR \< 30 mL/min/1\.73 m2\).
- •\- Androgen Deprivation Therapy within 6 months prior to enrolment.
Outcomes
Primary Outcomes
Not specified
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