PSMA-PET Guided Radiotherapy

Prostate Cancer Clinical Trial

— PSMA-PETgRT  

Official title:

PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03525288
• Other study ID #: 17.229
• Secondary ID: PERA GU17.1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: May 15, 2018
• Est. completion date: April 30, 2026

Study information

• Verified date: September 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: April 30, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.

2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.

3. ECOG 0-1

4. Charlson Cormobidity Index = 4

5. High-risk of distant metastases as defined by any of:

1. Oligometastases (=5) (regional or distant) identified on conventional staging, with = 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.

2. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.

3. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)

6. Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Exclusion Criteria:

1. Prior androgen deprivation therapy terminated < 12 months prior to enrollment.

2. Prior or planned PET scan.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• PSMA -PET/CT simulation
PET/CT simulation. If no additional lesions detected: RT as planned per standard care. If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT. If PSMA-PET/CT imaging consistent with widely metastatic disease (>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.
• Standard-care simulation
No PSMA-PET/CT as part of RT treatment planning.

Locations

Country	Name	City	State
Canada	CSSSL - Cité de la Santé Laval	Laval	Quebec
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	CHU de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival	Time to failure event	5 years
Secondary	Acute and delayed toxicities	Rate of Attributable Gr2+ toxicities (CTCAE v4.0)	5 years
Secondary	Rate of failure	Event rates	5 years
Secondary	Survival	Event rates	5 years
Secondary	Health-related quality of life	Qol measures	5 years
Secondary	Detection yield of PSMA PET imaging	Rate of new lesions identified on imaging	2 years