Prostate PMSABR Study

Prostate Cancer Clinical Trial

Official title:

PSMA-PET Guided Stereotactic Ablative Body Radiotherapy for Oligometastasis in Metastatic Castration-resistant Prostate Cancer (mCRPC) With Progression on Enzalutamide (PMSABR Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04742972
• Other study ID #: PST010
• Status: Withdrawn
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: December 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 16, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. 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.

2. 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.

3. 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
• Participants already receiving agents for the management of skeletal-related events (SREs) are allowed to continue with anti-bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa ligand inhibitor) if on stable dose for more than 28 days prior to treatment arm assignment

Exclusion Criteria:

• 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.
• PSA at inclusion >20 ng/ml
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• SABR
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.

Other:
• SOC
Three options: Continuation of Enzalutamide Observation Switch to next line treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Darren Poon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 6-month progression-Free Survival rate		up to 2 years
Secondary	Progression-Free Survival		2 years
Secondary	Time to progression		2 years
Secondary	Overall survival		2 years
Secondary	Local control rate of the SABR-treated oligometastasis at 6 months after SABR		up to 2 years
Secondary	Local control rate of the SABR-treated oligometastasis at 6 months after SABR based on the PERCIST criteria		up to 2 years
Secondary	QOL (EORTC QLQ-C30)		2 years
Secondary	Time to next systemic treatment		2 years
Secondary	The number of participants with treatment-related adverse event as assessed by CTCAE v4.0		2 years
Secondary	The proportion of patients in both arms who have AR-V7 (CTCs)		2 years