PSMA-PET Guided Radiotherapy for Prostate Cancer

(PSMA-PETgRT Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Androgen deprivation therapy, Prior PET scan

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had androgen deprivation therapy, it must have ended at least 12 months before joining the trial.

What data supports the effectiveness of the treatment PSMA-PET Guided Radiotherapy for Prostate Cancer?

Research shows that using 18F-DCFPyL PSMA PET/CT scans can significantly improve the detection of prostate cancer, especially in the pelvic lymph nodes, leading to better-targeted radiotherapy. In a study, patients who received this guided radiotherapy showed a favorable decrease in prostate-specific antigen (PSA) levels, indicating effective treatment. ^{1 2 3 4 5}

Is PSMA-PET Guided Radiotherapy for Prostate Cancer safe for humans?

The safety of [18F]DCFPyL, a compound used in PSMA-PET imaging for prostate cancer, has been evaluated in clinical trials. Initial studies have shown it to be safe for use in humans, with no major safety concerns reported. ^{4 6 7 8 9}

How is PSMA-PET Guided Radiotherapy for Prostate Cancer different from other treatments?

PSMA-PET Guided Radiotherapy for Prostate Cancer is unique because it uses a special imaging technique called PSMA-PET to precisely locate cancer cells, allowing for more targeted and personalized radiation treatment. This approach helps in accurately staging the tumor and potentially reducing unnecessary side effects by focusing the radiation more precisely on cancerous areas. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for men with high-risk localized prostate cancer or those who've had treated prostate cancer but now have rising PSA levels. They should have a small number (≤5) of metastases, be in good physical condition (ECOG 0-1), and not have received certain prior treatments like recent androgen deprivation therapy.

Inclusion Criteria

I have 5 or fewer cancer spread areas, with specific rules for counting.

I've had a bone scan and CT of my pelvis within the last 3 months.

I have high-risk prostate cancer with a CAPRA score between 6-10.

Exclusion Criteria

I have had or will have a PET scan.

I stopped hormone therapy for cancer less than a year ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy informed by PSMA-PET findings or standard care radiotherapy

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and survival outcomes after treatment

5 years

Treatment Details

Interventions

• [18F]DCFPyL
• Radiotherapy

Trial Overview The study compares two ways to plan radiotherapy: one uses a new type of PET/CT scan that's better at finding where the cancer has spread, while the other uses standard imaging. The goal is to see if using this new scan leads to better treatment outcomes.

Participant Groups

Group I: PSMA-PETgRT Experimental Treatment 1 Intervention

PSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan.

Group II: Standard Active Control 1 Intervention

Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+

Findings from Research

The study evaluated the dosimetry of the PET radiotracer 18F-DCFPyL in nine patients with metastatic prostate cancer, revealing that the lacrimal glands received the highest absorbed dose, which is important for understanding potential side effects during imaging and therapy.

Using advanced Monte-Carlo models, the research provided new insights into the dose received by the lacrimal and salivary glands, which are critical for assessing the safety and efficacy of 18F-DCFPyL in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. Plyku, D., Mena, E., Rowe, SP., et al.[2018]

The study of [(18)F]DCFPyL in nine prostate cancer patients showed that it is safe, with no major adverse events related to the radiotracer observed during the imaging process.

[(18)F]DCFPyL demonstrated high accumulation in prostate cancer sites, indicating effective targeting for imaging, and its radiation dose is comparable to other PET radiotracers, making it a viable option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Szabo, Z., Mena, E., Rowe, SP., et al.[2022]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

In a study of 30 patients with intermediate to high-risk primary prostate cancer, 18F-DCFPyL-PET/CT demonstrated a high accuracy in localizing clinically significant prostate cancer (csPCa), with a detection rate of 93% for recommended biopsy segments.

The diagnostic performance of 18F-DCFPyL-PET/CT showed a sensitivity of 61.4% and specificity of 88.3% for identifying csPCa, indicating its potential as a valuable tool for guiding targeted prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. Bodar, YJL., Jansen, BHE., van der Voorn, JP., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Changes in Management After 18F-DCFPyL PSMA PET in Patients Undergoing Postprostatectomy Radiotherapy, with Early Biochemical Response Outcomes. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

PSMA-PET guided dose-escalated volumetric arc therapy (VMAT) for newly diagnosed lymph node positive prostate cancer: Efficacy and toxicity outcomes at two years. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effective Prostate-Specific Membrane Antigen-Based 18F-DCFPyL-Guided Cryoablation of a Single Positive Site in a Patient Believed to Be More Metastatic on 11C-Choline PET/CT. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical impact of PSMA-based 18F-DCFBC PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

18F-Labeled Radiotracers for Prostate-specific Membrane Antigen: Historical Perspective and Future Directions. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Integration of (68)Ga-PSMA-PET imaging in planning of primary definitive radiotherapy in prostate cancer: a retrospective study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Prostate-specific membrane antigen positron emission tomography in prostate cancer: a step toward personalized medicine. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A survey among German-speaking radiation oncologists on PET-based radiotherapy of prostate cancer. [2022]

13. England pubmed.ncbi.nlm.nih.gov

PSMA-PET based radiotherapy: a review of initial experiences, survey on current practice and future perspectives. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Metastasis-Free Survival and Patterns of Distant Metastatic Disease After Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA-PET)-Guided Salvage Radiation Therapy in Recurrent or Persistent Prostate Cancer After Prostatectomy. [2022]