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EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC (ANZUP2001)

Primary Purpose

Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
177Lu-PSMA-617
Ipilimumab
Nivolumab
Sponsored by
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18 years or older, with histologically confirmed adenocarcinoma of the prostate.
  2. Castration-resistant metastatic prostate cancer (defined as disease progressing despite castration by orchidectomy or ongoing luteinising hormone-releasing hormone agonist or antagonist).
  3. Patients must have progressed on prior novel AR targeted agents for treatment of prostate cancer. Progressive disease defined by at least one of the following:

    • PSA progression, minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 5ng/ml
    • Soft tissue or visceral disease progression as per RECIST 1.1
    • Bone progression: ≥ 2 new lesions on bone scan as per PCWG3
  4. Target or non-target lesions according to RECIST 1.1 and PCWG3
  5. Significant PSMA avidity on PET/CT using 68GaPSMA, defined as SUVmax ≥15 at a site of disease, and SUVmax ≥ 10 at other sites of disease ≥10mm (where there is no impact from partial voluming.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  7. Adequate bone marrow, hepatic and renal function documented within 28 days of registration, defined as:

    • Haemoglobin ≥90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks)
    • Absolute neutrophil count ≥1.5x109/L
    • Platelets ≥100 x109/L
    • Total bilirubin ≤1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome
    • Aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤2.5 × ULN or ≤5 × ULN for participants with liver metastases
    • Serum creatinine ≤1.5 x ULN or a calculated creatinine clearance > 50mL/min (Cockcroft-Gault equation)
  8. Patients must have a life expectancy ≥ 24 weeks.
  9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
  10. Signed, written informed consent.

Exclusion Criteria:

  1. Prostate cancer with known significant sarcomatoid, spindle cell or neuroendocrine cell components, or metastasis of other cancers to the prostate.
  2. 18F-FDG-PET/CT SUVmax ≥10 at a site of measurable disease with no concurrent PSMA expression > 10mm
  3. Prior treatment with anti-PD1, anti-PD-L1/L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.
  4. Patients must not have had more than one line of chemotherapy. If a patient has had docetaxel chemotherapy for hormone sensitive or castrate resistant setting, this will be considered one line.
  5. Prior treatment with 177Lu-PSMA.
  6. Patients with active, known, or suspected autoimmune disease. Sjogren's syndrome is considered an autoimmune disease. Exceptions: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger, may be eligible.
  7. Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  8. Participants must have recovered from all AE due to previous therapies to ≤Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible.
  9. Active malignancies within the previous 2-years with >30% probability of recurrence within 1 year. Melanoma in situ, basal cell or squamous cell carcinomas of skin, are permitted.
  10. Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated.
  11. Radiation or surgery within 2 weeks of randomisation.
  12. Previous history of interstitial lung disease or non-infectious pneumonitis.
  13. Administration of a live vaccine within 30 days prior to the first dose of study drug.
  14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  15. Inadequate contraception. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Sites / Locations

  • St Vincents Hospital
  • Calvary Mater Newcastle
  • Royal Brisbane and Womens hospital
  • Royal Adelaide Hospital
  • Austin Health
  • Peter MacCallum Cancer CentreRecruiting
  • Alfred Hospital
  • Sir Charles Gairdner

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Combination 177Lu-PSMA-617, Ipilimumab & Nivolumab

177Lu-PSMA-617

Arm Description

177Lu-PSMA (7.5GBq) given every 6 weeks up to 6 cycles in combination with concurrent ipilimumab (3mg/kg Q6W x 4 doses) and nivolumab (1mg/kg Q3W x 8 doses) followed by nivolumab monotherapy (480mg Q4W up to 18 doses) or until disease progression or unacceptable toxicity.

177Lu-PSMA (7.5GBq) given every 6 weeks up to 6 cycles or until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

PSA progression free survival (PSA-PFS) at 1 year (PCWG3)
PSA progression is defined as a rise in PSA by ≥ 25% AND ≥ 2 ng/mL above the nadir (lowest PSA point). This needs to be confirmed by a repeat PSA performed at least 3 weeks later.

Secondary Outcome Measures

PSA response rate (PSA-RR)
PSA response rate is defined as the proportion of participants in each group with a PSA reduction of ≥ 50% from baseline.
Frequency and severity of adverse events (CTCAE v5.0)
CTCAE v5.0 will be used to measure frequency and severity of AEs during study treatment.
Radiological progression free survival (PCWG3/RECIST1.1)
Radiographic PFS is defined as the interval from the date of randomisation to the date of first evidence of radiographic progression, or the date of last known follow-up without progression.
PSA progression free survival (PCWG3)
PSA progression free survival is defined as the interval from the date of randomisation to the date of first evidence of PSA progression or the date of last known follow-up without PSA progression.
Overall survival (OS)
OS is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known follow-up alive.
Objective response rate (ORR)
ORR is defined as partial or complete response at any stage of the study (from the date of randomisation to date of subsequent anti-cancer treatment). RECIST 1.1 will be used to assess ORR in participants with measurable disease.
Duration of response
Duration of response is defined as the interval from the date of first response (Complete Response / Partial Response as per RECIST 1.1) to the date of first documented radiological progression as per RECIST 1.1 in participants with measurable disease.
Time to treatment response
Time to treatment response is defined as the interval from the date of randomisation to the date of first response (Complete Response / Partial Response as per RECIST 1.1) in participants with measurable disease.
Aspects of Health Related Quality of Life (HRQoL) - 1
The EORTC QLQ-C30 (European Organisation for Research on Treatment of Cancer - Quality of Life Questionnaire for cancer patients) instrument uses 28 questions about overall quality of life with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 28 indicating a better quality of life and higher scores with a maximum of 112 indicating lower overall quality of life. The questionnaire also has two summary questions which asks participants to rank 1) overall health and 2) overall quality of life on scale of from 1 (very poor) to 7 (excellent).
Aspects of Health Related Quality of Life (HRQoL) - 2
Patient DATA Form (Patient Disease and Treatment Assessment Form - 47 items) is a simple, multi-item quality of life instrument based on 11-point numeric rating scales for a range of relevant symptoms and functions. It combines cancer specific items from the UBQ-C, GLQ-8 and LASA cancer-specific quality of life instruments.

Full Information

First Posted
September 30, 2021
Last Updated
June 9, 2022
Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborators
Prostate Cancer Foundation of Australia, Bristol-Myers Squibb, Advanced Accelerator Applications, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT05150236
Brief Title
EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC
Acronym
ANZUP2001
Official Title
Phase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborators
Prostate Cancer Foundation of Australia, Bristol-Myers Squibb, Advanced Accelerator Applications, University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II study will investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC).
Detailed Description
This is an open label, randomised, stratified, multicentre phase 2 clinical trial recruiting 110 participants over 18 months and followed for 12 months. Participants will be randomised to 177Lu-PSMA in combination with Ipilimumab and Nivolumab and 177Lu-PSMA alone in a 2:1 ratio (using minimisation with a random component) stratified by prior exposure to docetaxel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Prostate Cancer, Neoplasms by Site, Neoplasms, Prostatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination 177Lu-PSMA-617, Ipilimumab & Nivolumab
Arm Type
Experimental
Arm Description
177Lu-PSMA (7.5GBq) given every 6 weeks up to 6 cycles in combination with concurrent ipilimumab (3mg/kg Q6W x 4 doses) and nivolumab (1mg/kg Q3W x 8 doses) followed by nivolumab monotherapy (480mg Q4W up to 18 doses) or until disease progression or unacceptable toxicity.
Arm Title
177Lu-PSMA-617
Arm Type
Experimental
Arm Description
177Lu-PSMA (7.5GBq) given every 6 weeks up to 6 cycles or until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
177Lu-PSMA-617
Other Intervention Name(s)
177Lutetium -PSMA 617 also referred to as 177Lu-PSMA
Intervention Description
Patients will be given 7.5GBq of Lu-PSMA every 6 weeks up to 6 cycles unless there is unacceptable toxicity, commencing following result of 68Ga-PSMA PET within 28 days of registration.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
YERVOY
Intervention Description
Patients will be given 3mg/kg of Ipilimumab every 6 weeks up to 4 doses unless there is unacceptable toxicity, concurrently with Lu-PSMA and Nivolumab.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
OPDIVO
Intervention Description
Patients will be given 1mg/kg of Nivolumab every 3 weeks up to 8 doses, concurrently with Lu-PSMA and Ipilimumab unless there is unacceptable toxicity. Followed by 480mg nivolumab monotherapy commencing at week 32. Nivolumab monotherapy will be given to patients every 4 weeks up to 18 doses, or until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
PSA progression free survival (PSA-PFS) at 1 year (PCWG3)
Description
PSA progression is defined as a rise in PSA by ≥ 25% AND ≥ 2 ng/mL above the nadir (lowest PSA point). This needs to be confirmed by a repeat PSA performed at least 3 weeks later.
Time Frame
Date of randomisation to the date of first evidence of PSA progression at 53 weeks post randomisation.
Secondary Outcome Measure Information:
Title
PSA response rate (PSA-RR)
Description
PSA response rate is defined as the proportion of participants in each group with a PSA reduction of ≥ 50% from baseline.
Time Frame
Date of randomisation through to study completion, approximately 3 years from start of recruitment. Early rises in PSA prior to 12 weeks will be disregarded in determining PSA response.
Title
Frequency and severity of adverse events (CTCAE v5.0)
Description
CTCAE v5.0 will be used to measure frequency and severity of AEs during study treatment.
Time Frame
Date of first dose of study treatment until 100 days after cessation of study treatment.
Title
Radiological progression free survival (PCWG3/RECIST1.1)
Description
Radiographic PFS is defined as the interval from the date of randomisation to the date of first evidence of radiographic progression, or the date of last known follow-up without progression.
Time Frame
Date of randomisation to the date of first evidence of progression on imaging (PCWG3 criteria for bone lesions and RECIST 1.1 for soft tissue lesions) assessed every 12 weeks through to study completion, approximately 3 years from start of recruitment.
Title
PSA progression free survival (PCWG3)
Description
PSA progression free survival is defined as the interval from the date of randomisation to the date of first evidence of PSA progression or the date of last known follow-up without PSA progression.
Time Frame
Date of randomisation through to study completion, approximately 3 years from start of recruitment.
Title
Overall survival (OS)
Description
OS is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known follow-up alive.
Time Frame
Through to study completion, approximately 3 years from start of recruitment.
Title
Objective response rate (ORR)
Description
ORR is defined as partial or complete response at any stage of the study (from the date of randomisation to date of subsequent anti-cancer treatment). RECIST 1.1 will be used to assess ORR in participants with measurable disease.
Time Frame
Date of randomisation through to study completion, approximately 3 years from start of recruitment.
Title
Duration of response
Description
Duration of response is defined as the interval from the date of first response (Complete Response / Partial Response as per RECIST 1.1) to the date of first documented radiological progression as per RECIST 1.1 in participants with measurable disease.
Time Frame
Date of randomisation through to first radiological progression or through to study completion, approximately 3 years from start of recruitment.
Title
Time to treatment response
Description
Time to treatment response is defined as the interval from the date of randomisation to the date of first response (Complete Response / Partial Response as per RECIST 1.1) in participants with measurable disease.
Time Frame
Date of randomisation through to study completion, approximately 3 years from start of recruitment.
Title
Aspects of Health Related Quality of Life (HRQoL) - 1
Description
The EORTC QLQ-C30 (European Organisation for Research on Treatment of Cancer - Quality of Life Questionnaire for cancer patients) instrument uses 28 questions about overall quality of life with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 28 indicating a better quality of life and higher scores with a maximum of 112 indicating lower overall quality of life. The questionnaire also has two summary questions which asks participants to rank 1) overall health and 2) overall quality of life on scale of from 1 (very poor) to 7 (excellent).
Time Frame
Within 7 days prior to randomisation, assessed every 12 weeks, through to study completion, approximately 3 years from start of recruitment.
Title
Aspects of Health Related Quality of Life (HRQoL) - 2
Description
Patient DATA Form (Patient Disease and Treatment Assessment Form - 47 items) is a simple, multi-item quality of life instrument based on 11-point numeric rating scales for a range of relevant symptoms and functions. It combines cancer specific items from the UBQ-C, GLQ-8 and LASA cancer-specific quality of life instruments.
Time Frame
Within 7 days prior to randomisation, assessed every 12 weeks, through to study completion, approximately 3 years from start of recruitment.
Other Pre-specified Outcome Measures:
Title
Association between Clinical Outcomes and Possible Prognostic/Predictive Biomarkers (tissue and circulating) including PBMCs, ctDNA and CTCs
Description
Translational research will include identifying tissue and circulating biomarkers that are prognostic and/or predictive of response to treatment, safety and resistance to study treatment. These include but are not limited to analyses of: PBMC samples may be used for immunophenotyping or characterisation of the immune cell subsets in the periphery; ctDNA, immunological markers, and response data will be used to prospectively investigate the utility of early changes in ctDNA levels; CTCs may be enumerated and analysed for their potential to predict or correlate with toxicity and efficacy of immune checkpoint inhibitors.
Time Frame
Date of randomisation through to study completion, approximately 3 years from start of recruitment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older, with histologically confirmed adenocarcinoma of the prostate. Castration-resistant metastatic prostate cancer (defined as disease progressing despite castration by orchidectomy or ongoing luteinising hormone-releasing hormone agonist or antagonist). Patients must have progressed on prior novel AR targeted agents for treatment of prostate cancer. Progressive disease defined by at least one of the following: PSA progression, minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 5ng/ml Soft tissue or visceral disease progression as per RECIST 1.1 Bone progression: ≥ 2 new lesions on bone scan as per PCWG3 Target or non-target lesions according to RECIST 1.1 and PCWG3 Significant PSMA avidity on PET/CT using 68GaPSMA, defined as SUVmax ≥15 at a site of disease, and SUVmax ≥ 10 at other sites of disease ≥10mm (where there is no impact from partial voluming. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Adequate bone marrow, hepatic and renal function documented within 28 days of registration, defined as: Haemoglobin ≥90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks) Absolute neutrophil count ≥1.5x109/L Platelets ≥100 x109/L Total bilirubin ≤1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome Aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤2.5 × ULN or ≤5 × ULN for participants with liver metastases Serum creatinine ≤1.5 x ULN or a calculated creatinine clearance > 50mL/min (Cockcroft-Gault equation) Patients must have a life expectancy ≥ 24 weeks. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments Signed, written informed consent. Exclusion Criteria: Prostate cancer with known significant sarcomatoid, spindle cell or neuroendocrine cell components, or metastasis of other cancers to the prostate. 18F-FDG-PET/CT SUVmax ≥10 at a site of measurable disease with no concurrent PSMA expression > 10mm Prior treatment with anti-PD1, anti-PD-L1/L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways. Patients must not have had more than one line of chemotherapy. If a patient has had docetaxel chemotherapy for hormone sensitive or castrate resistant setting, this will be considered one line. Prior treatment with 177Lu-PSMA. Patients with active, known, or suspected autoimmune disease. Sjogren's syndrome is considered an autoimmune disease. Exceptions: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger, may be eligible. Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants must have recovered from all AE due to previous therapies to ≤Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. Active malignancies within the previous 2-years with >30% probability of recurrence within 1 year. Melanoma in situ, basal cell or squamous cell carcinomas of skin, are permitted. Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Radiation or surgery within 2 weeks of randomisation. Previous history of interstitial lung disease or non-infectious pneumonitis. Administration of a live vaccine within 30 days prior to the first dose of study drug. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Inadequate contraception. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret McJannett
Phone
+61295625033
Email
trials@anzup.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Izabella Pokorski
Phone
+61295625000
Email
evolution.study@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahneen Sandhu, MBBS, FRACP
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Study Chair
Facility Information:
Facility Name
St Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Joshua
Email
Anthony.Joshua@svha.org.au
First Name & Middle Initial & Last Name & Degree
Louise Emmett, MBBS, FRACP
Email
louise.emmett@svha.org.au
First Name & Middle Initial & Last Name & Degree
Anthony Joshua, MBBS FRACP
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Dr Gedye
Email
craig.gedye@newcastle.edu.au
First Name & Middle Initial & Last Name & Degree
Natalie Rutherford
Facility Name
Royal Brisbane and Womens hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Goh
Email
Jeffrey.Goh@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
David Pattison
Email
David.Pattison@health.qld.gov.au
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang Tan, MBBS FRACP
Phone
+61 7074 2336
Email
hsiang.tan@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Ian Kirkwood, MBBS FRACP
Phone
(08) 7074 0283
Email
Ian.Kirkwood@sa.gov.au
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Weickhardt, MBBS, FRACP
Phone
+61 3 9496 5763
Email
andrew.weickhardt@onjcri.org.au
First Name & Middle Initial & Last Name & Degree
Sze Ting Lee, MBBS, FRACP
Phone
+61 3 9496 3063
Email
SzeTing.LEE@austin.org.au
First Name & Middle Initial & Last Name & Degree
Andrew Weickhardt, MBBS, FRACP
First Name & Middle Initial & Last Name & Degree
Sze Ting Lee, MBBS, FRACP
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A/Prof Shahneen Sandhu, MBBS FRACP
Email
Shahneen.Sandhu@petermac.org
First Name & Middle Initial & Last Name & Degree
Alipour Ramin, MBBS, FRACP
Email
Ramin.Alipour@petermac.org
First Name & Middle Initial & Last Name & Degree
Dr Ben Tran, MBBS, FRACP
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Voskoboynik
Email
m.voskoboynik@alfred.org.au
First Name & Middle Initial & Last Name & Degree
David Nadebaum
Email
D.Nadebaum@alfred.org.au
Facility Name
Sir Charles Gairdner
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Siobhan Ng
Email
siobng@optusnet.com.au
First Name & Middle Initial & Last Name & Degree
A/Prof Roslyn Francis
Email
Ros.Francis@health.wa.gov.au

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Study protocol will be published in a peer-reviewed journal within 24 months.

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EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC

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