Detecting new bone metastases in patients on androgen deprivation therapy

Not Applicable

• Conditions: Prostate Cancer; Cancer - Prostate; Cancer - Bone

• Registration Number: ACTRN12618001696280
• Lead Sponsor: The Garvan Institues of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-15
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Pathologically confirmed adenocarcinoma of prostate
- Men presenting high risk of metastatic disease.
- Gleason score 7-10
- Deemed suitable by a medical oncologist to start targeted radiation therapy and androgen deprivation therapy.
- Blood tests:
a) haemoglobin > 100g/L
b) Platelets > 100 x 10^9/L
c) Total white cell count > 4 x 10^9/L
-Willingness to give written, informed consent and willingness to participate in and comply with the study.

Exclusion Criteria

- Participants whose prostate cancer is not high risk of metastasis;
- Participants who refuse to join the trial or are unable consent;
- Participants who cannot remain still for at least 30 minutes to comply with imaging requirements.
- Participants who have no PSMA receptor activity (approximately 5-10% of the population) and provide a negative baseline scan.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of new bone lesions identified on 68Ga-PSMA PET CT scan[At 6 months and 12 months post enrolment]

Secondary Outcome Measures

Name	Time	Method
The proportion of participants who started bisphosphonates or other therapeutics designed to block bone reabsorption as measured by medication history[At 12 months post enrolment];Change in Lactate dehydrogenase (LDH) levels in blood from baseline [6 and 12 months post enrolment];Change in complete blood count (CBC) levels in blood from baseline[6 and 12 months post enrolment];Change in electrolytes urea creatinine (EUC) levels in blood from baseline[6 and 12 months post enrolment];Change in calcium-magnesium-phosphate (CMP) levels in blood from baseline[6 and 12 months post enrolment];Change in Testosterone levels in blood from baseline[6 and 12 months post enrolment];Change in liver function test (LFT) levels in blood from baseline[6 and 12 months post enrolment];Change in prostate specific antigen (PSA) levels in blood from baseline[6 and 12 months post enrolment]