ocal cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment

Not Applicable

• Conditions: Prostate cancer; metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN58401737
• Lead Sponsor: Imperial College London and Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-21
• Last Update Posted: 4 September 2023
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 399

Inclusion Criteria

1. Diagnosed with prostate cancer within 6 months of screening visit
2. Metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level
3. Fit to undergo standard of care treatment for metastatic disease and both minimally invasive therapy and prostate radiotherapy/prostatectomy
4. Performance status 0-2
5. Histologically proven local tumour

Exclusion Criteria

Added 23/08/2023: Current exclusion criteria as of 06/10/2021:
1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI.
2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 6 months of screening visit.
3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above)

Previous exclusion criteria from 08/02/2021 to 06/10/2021:
1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-Ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all
preceding scans mentioned here) AND prostate MRI
2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 4 months of screening visit
3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above in Exclusion Criteria 2)

Previous exclusion criteria:
1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-Ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI
2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 3 months of randomisation
3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above in Exclusion Criteria 2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified