Prostate PMSABR Study

NCT04742972 | Withdrawn

• 1 other identifier: PST010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigator aim to evaluate the role of PMSA-PET guided SABR on progression free survival (PFS) in patients with oligoprogressive mCRPC with Enzalutamide. The potential improvement in PFS with SABR while continuing the initial-responding Enzalutamide is potentially benefiting to patients in terms of overall disease control.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The 6-month progression-Free Survival rate

  up to 2 years

Secondary Outcomes (9)

• Progression-Free Survival

  2 years

• Time to progression

  2 years

• Overall survival

  2 years

• Local control rate of the SABR-treated oligometastasis at 6 months after SABR

  up to 2 years

• Local control rate of the SABR-treated oligometastasis at 6 months after SABR based on the PERCIST criteria

  up to 2 years

Study Arms (2)

SABR

EXPERIMENTAL

Radiation: SABR

SOC

PLACEBO COMPARATOR

Other: SOC

Interventions

SABR RADIATION

SABR is delivered to all sites of oligometastasis with continuation of Enzalutamide. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in SOC Arm.

SABR

SOC OTHER

Three options: 1. Continuation of Enzalutamide 2. Observation 3. Switch to next line treatment

SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of prostate adenocarcinoma
• Evidence of stage IV disease (as defined by AJCC criteria) on previous bone, CT, and/or MRI scan
• Ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (ie, surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
• ECOG performance score 0-2
• Age ≥ 18
• History/physical examination within 2 weeks prior to registration
• Able to sign informed-consent
• Patient with mCRPC who received Enzalutamide during the past 6-8 weeks and must have been delivered for a total of at least 3 months with an initial ≥50% decline of PSA from baseline.
• Documented disease progression with Enzalutamide as defined by PCWG3 with at least one of the followings:
• PSA progression: defined by PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir. A minimum of 2 rising PSA levels with an interval of ≥ 1 week between each determination.
• Radiographic disease progression in soft tissue based on RECIST 1.1 criteria. Participants whose disease spread is limited to regional pelvic lymph nodes (N1) measuring at least 2 cm in short axis will be considered eligible.
• Radiographic disease progression in bone defined as appearance of 2 or more new bone lesions on bone scan
• A maximum of 5 extracranial metastases in any organ system (except brain), with ≤ 4 tumours within any given organ system, confirmed with PSMA PET-CT scan
• All sites of oligometastasis can be safely treated with SABR
• Adequate baseline organ function to allow SABR to all relevant targets

You may not qualify if:

• Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
• Prior treatment with docetaxel, another chemotherapy agent or second generation hormonal therapy (e.g. abiraterone acetate or enzalutamide) for metastatic castration-resistant prostate cancer. Prior docetaxel, abiraterone acetate or enzalutamide for metastatic hormone-sensitive prostate cancer is allowed if ≥ 12 months elapsed from last dose of these treatments.
• Serum creatinine and total bilirubin \> 3 times the upper limit of normal
• Liver Transaminases \> 5-times the upper limit of normal
• Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Patients with oligometastases that have been previously treated with SABR.
• Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease
• Clinical or radiological evidence of spinal cord compression or tumor within 1.5mm of spinal cord on MRI
• Malignant pleural effusion
• Malignant peritoneal disease
• Intra-cranial metastases

Sponsors & Collaborators

• Darren Poon: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: February 25, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 16, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share