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Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8Phase 3PSMA-dRTNCT04457245

Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer

A Phase 3 study testing Computed Tomography, Fluorine F 18 DCFPyL and Positron Emission Tomography in people with Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 and Stage II Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Computed Tomography, Fluorine F 18 DCFPyL and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
14 Aug 2020to 10 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

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]

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).

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Computed Tomography, Fluorine F 18 DCFPyL, Positron Emission Tomography, Radiation Therapy
Keywords
PSMA, PET/CT, randomized trial, definitive Radiation Therapy, prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo whole body PET/CT

  • Fluorine F 18 DCFPyLOther

    Also called 18F-DCFPyL

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo whole body PET/CT

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Undergo standard of care definitive radiation therapy

Study groups in NCT04457245
Study groupRoleWhat they receive
Arm I (dRT)Active comparator150 Patients undergo standard dRT at the discretion of the treating radiation oncologist. Patient does not undergo PSMA PET for RT planning. Any other imaging is allowed, including CT/BS/MR/PET depending on local practice. No other primary treatment can be given before dRT. If a patient assigned to the control arm undergo a PSMA PET scan at another institution he will be discontinued from the study.
Receives: Radiation: Radiation Therapy
Arm II (18F-DCFPyL, PET/CT, dRT)Experimental162 Patient undergoes PSMA PET with 18F-DCFPyL for dRT planning. Any other imaging is allowed, including CT/BS/MR/PET depending on local practice. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives PSMA PET results and images. No other primary treatment can be given before RT.
Receives: Procedure: Computed Tomography; Other: Fluorine F 18 DCFPyL; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of definitive radiation therapy (dRT)

    Will be measured as progression-free survival after initiation of dRT. Progression is defined as (whichever occurs first): A biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir prostate specific antigen (PSA) (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy, appearance of metastasis or loco-regional recurrence (diagnosed by any imaging or biopsy), initiation of any new salvage therapy or death from any cause. Survival curves will be constructed using the Kaplan-Meier method.

    Measured: From date of randomization to first occurrence of progression, assessed up to 5 years

Secondary outcomes (6)

  1. Loco-regional progression free survival

    Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.

    Measured: Up to 5 years after the date of randomization

  2. Metastasis-free survival after initiation of radiation therapy (RT)

    Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.

    Measured: Up to 5 years after the date of randomization

  3. Overall survival

    Measured: Up to 5 years after the date of randomization

  4. Change in initial treatment intent

    Will estimate the proportion of subjects in the prostate-specific membrane antigen (PSMA) group that have a change in the initial treatment intent and compute a 95% confidence interval for that proportion.

    Measured: Baseline up to 5 years after the date of randomization

  5. PSMA positron emission tomography (PET) derived predictors of progression-free survival

    Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.

    Measured: Up to 5 years after the date of randomization

  6. PSMA PET derived predictors of overall survival

    Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.

    Measured: Up to 5 years after the date of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start14 Aug 2020
  3. Primary completion10 Jan 2023
  4. Study completion10 Jan 2023

Why it stopped: accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457245
Sponsor's protocol ID
20-000378
Other IDs
NCI-2020-03445
Acronym
PSMA-dRT
Status last verified
Jan 2023
First submitted
30 Jun 2020
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nikitas J, Lam E, Booker KA, Fendler WP, Eiber M, Hadaschik B, Herrmann K, Hirmas N, Lanzafame H, Stuschke M, Czernin J, Steinberg ML, Nickols NG, Kishan AU, Calais J. Randomized Trial of Prostate-Specific Membrane Antigen PET/CT Before Definitive Radiotherapy for Unfavorable Intermediate- and High-Risk Prostate Cancer (PSMA-dRT Trial). J Nucl Med. 2024 Jul 1;65(7):1076-1079. doi: 10.2967/jnumed.123.267004.

    PubMed 38664019

  • 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.

    PubMed 33962579

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Computed Tomography, Fluorine F 18 DCFPyL and Positron Emission Tomography in people with Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 and Stage II Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of definitive radiation therapy (dRT) (time frame: From date of randomization to first occurrence of progression, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457245, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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