Clinical trial NCT04457245: Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer
Official title: Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Keywords: PSMA
PET/CT
randomized trial
definitive Radiation Therapy
prostate cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2020-07-07
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).

Detailed description: PRIMARY OBJECTIVE:

I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-based dRT.

OUTLINE: Patients are randomized to 1 of 2 arms. In both arms, no other primary treatment should be given before RT.

Arm I: Patients do not undergo PSMA PET for dRT planning. Patients undergo standard of care dRT at the discretion of the treating radiation oncologist.

Arm II: Patients undergo PSMA PET for dRT planning. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images.

After completion of dRT, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. The investigators will rely on the medical records obtained from the treating physicians as the primary source of outcome data.

Eligibility criteria: Inclusion Criteria:

* Adult male 18 years or older
* Histopathologically-proven PCa
* Unfavorable IR to HR disease:

  * Prostate specific antigen (PSA) \>= 10 ng/mL
  * Or cT-stage \>= 2b
  * Or Gleason grade 3 (4+3=7) or higher
  * Or Gleason grade 2 (3+4=7) AND \>= 50% positive biopsy cores
  * Or Decipher Score \>= 0.45
* Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2)
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Less than 18 years old at the time of investigational product administration
* Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization
* Prior PSMA PET
* Prior pelvic RT
* Contraindications to radiotherapy (including active inflammatory bowel disease)
* Concurrent or prior surgery or systemic therapy for PCa at the time of randomization

Primary outcomes:
measure: Success rate of definitive radiation therapy (dRT)
timeFrame: From date of randomization to first occurrence of progression, assessed up to 5 years
Secondary outcomes:
measure: Loco-regional progression free survival
timeFrame: Up to 5 years after the date of randomization
measure: Metastasis-free survival after initiation of radiation therapy (RT)
timeFrame: Up to 5 years after the date of randomization
measure: Overall survival
timeFrame: Up to 5 years after the date of randomization
measure: Change in initial treatment intent
timeFrame: Baseline up to 5 years after the date of randomization
measure: PSMA positron emission tomography (PET) derived predictors of progression-free survival
timeFrame: Up to 5 years after the date of randomization
measure: PSMA PET derived predictors of overall survival
timeFrame: Up to 5 years after the date of randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jeremie Calais
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calais J, Zhu S, Hirmas N, Eiber M, Hadaschik B, Stuschke M, Herrmann K, Czernin J, Kishan AU, Nickols NG, Elashoff D, Fendler WP. Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol. BMC Cancer. 2021 May 7;21(1):512. doi: 10.1186/s12885-021-08026-w.