PSMA-PET Guided Radiotherapy for Prostate Cancer

(PSMA-PETgRT Trial)

Not currently recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to enhance prostate cancer treatment using a special scan called PSMA-PET. The goal is to determine if this scan can help doctors target cancer more accurately than standard methods like CT or bone scans, potentially improving treatment outcomes. Participants will receive either radiotherapy guided by PSMA-PET results or standard radiotherapy without the scan. The trial seeks men diagnosed with prostate cancer who are at high risk of cancer spreading and plan to undergo curative radiotherapy.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking advancements in prostate cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that [18F]DCFPyL, a special imaging tool for prostate cancer, is generally safe. In one study, patients experienced no significant side effects, indicating it is well-tolerated. Another study found that this imaging method detected cancer spread more effectively than standard methods, without adding major risks.

Radiotherapy, used alongside the imaging, is a common and generally safe treatment for prostate cancer, though it can cause side effects like tiredness or skin irritation. Overall, current research suggests that combining [18F]DCFPyL imaging with radiotherapy is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a new way of using imaging technology to improve prostate cancer treatment. Unlike the standard radiotherapy, which targets the prostate gland based on traditional imaging techniques, this trial uses PSMA-PET/CT imaging to identify and include up to five additional cancer sites in the treatment plan. This targeted approach could potentially enhance the accuracy and effectiveness of radiotherapy by addressing cancer spread that might otherwise go undetected. By doing so, the trial aims to improve outcomes for patients with prostate cancer by tailoring treatment more precisely to their individual needs.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare two approaches for treating prostate cancer. One group of participants will receive PSMA-PET guided radiotherapy, using [18F]DCFPyL during treatment planning to enhance radiotherapy's effectiveness. Research has shown that [18F]DCFPyL with radiotherapy improves cancer detection, even at low PSA levels, allowing doctors to target cancerous areas more accurately. PSMA-PET imaging has improved how doctors determine cancer stages and plan treatment, making radiotherapy more precise. This approach shows promise for both early and advanced stages of prostate cancer and may lead to better patient outcomes. Meanwhile, the other group will receive standard care radiotherapy without PSMA-PET/CT imaging. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429625000475

PSMA-PET Guided Radiotherapy in Prostate Cancer The synergy between PSMA-PET and radiotherapy enables a more effective therapeutic approach across both early and advanced stages of PCa.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36713978/

18F-DCFPyL (PSMA) PET as a radiotherapy response ... Results: The majority of MDRT-treated lesions showed lack of PSMA-PET/CT avidity, suggesting treatment response even after low biological ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... [¹⁸F]PSMA-1007 demonstrated superior lesion detection at low PSA levels (<0.5 ng/mL), achieving a DR of 84% compared to 68% for [⁶⁸Ga]Ga-PSMA-11 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025452/

Impact of PSMA-PET/CT on Radiotherapy Decisions PSMA-PET/CT is changing prostate cancer management by significantly enhancing the accuracy of staging and treatment planning, particularly in radiotherapy.

5. redjournal.org redjournal.org/article/S0360-3016(23)06592-6/fulltext

DCFPyL PSMA Radiotracer in Patients with Prostate Cancer This study is a pioneering effort to evaluate the quality of BgRT plans for prostate cancer patients using the [18F]-DCFPyL PSMA radiotracer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531836/

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... Here we present initial safety, biodistribution, and radiation dosimetry results with [18F]DCFPyL, a second-generation fluorine-18-labeled small-molecule PSMA ...

7. advancesradonc.com advancesradonc.com/article/S2452-1094(25)00189-7/fulltext

DCFPyL PSMA Imaging on the RefleXion X1 PET-CT ... Data from this study would allow assessment of the technical performance of the PET imaging subsystem in patients with prostate cancer ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03525288

NCT03525288 | PSMA-PET Guided Radiotherapy [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1587

A Prospective Study on 18 F-DCFPyL PSMA PET/CT ... We evaluated the safety, sensitivity, and impact on patient management of 18F-DCFPyL in the setting of biochemical recurrence of prostate cancer ...