PSMA PET-Guided Radiotherapy for Prostate Cancer

Recruiting at 1 trial location

Overseen By Liliana Robles

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Must be taking: GnRH agonists

Must not be taking: Investigational agents

Disqualifiers: Prior prostatectomy, Allergic to PMSA-11, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal use of a special imaging technique, PSMA PET, to enhance radiotherapy for prostate cancer. The goal is to determine the best timing and spacing for treatments to effectively target the cancer. Participants will receive a combination of radiotherapy and hormone therapy, with varying schedules to identify the most effective approach. Men with high-risk prostate cancer, who plan to start these therapies and show no signs of cancer spread, are suitable candidates for the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing androgen deprivation therapy (ADT) is allowed under certain conditions, and you cannot be on other investigational cancer treatments.

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

Research has shown that [68Ga]Ga-PSMA-11, the treatment used in this trial, is generally safe and well-tolerated. The FDA approved it as the first of its kind for medical use, indicating a strong safety record. Other studies found that this treatment did not cause serious side effects related to the drug itself. These results are promising for its use in people. Although this trial is in its early stages, previous approvals and studies support its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of 68-Ga PSMA11 in radiotherapy for prostate cancer because it offers a more targeted approach than conventional treatments. Unlike standard options that generally involve broad radiation methods, 68-Ga PSMA11 employs a specific PET imaging technique to identify and adaptively focus on dominant intra-prostatic lesions. This precision could lead to more effective targeting of cancer cells, potentially improving outcomes and minimizing damage to surrounding healthy tissue. Additionally, the use of PSMA PET-guided radiotherapy allows for real-time assessment and adjustment of the treatment, enhancing its adaptability and precision.

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

Research has shown that 68-Ga PSMA-11 effectively identifies prostate cancer. In some studies, this imaging method altered treatment plans for 53% of patients with recurrent prostate cancer. It uses a PET scan to highlight cancerous areas, allowing doctors to pinpoint the cancer's location. This precise targeting can lead to improved treatment plans and outcomes. In this trial, participants will receive different schedules of SAbR treatment, with 68-Ga PSMA-11 PET scans used before and during treatment to assess and adapt the boost dose to dominant intra-prostatic lesions. This method may also help predict the effectiveness of other prostate cancer treatments, making 68-Ga PSMA-11 crucial for customizing treatments for each patient. ^{2 4 6 7 8}

Who Is on the Research Team?

Neil Desai, MD MHS

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

Men over 18 with high-risk prostate cancer confirmed within the last 180 days, no distant metastases, and a PSMA-avid lesion in the prostate. They must plan to undergo stereotactic ablative radiotherapy (SabR) with hormone therapy, have an AUA IPSS score ≤18, a prostate size ≤100cc, and agree to use contraception during treatment and for six months after.

Inclusion Criteria

My prostate cancer is high risk, confirmed by a recent test.

My recent scans show no signs of cancer spread far from the original site.

I agree to use effective birth control or abstain from sex for 6 months during and after the study.

Exclusion Criteria

All other inclusion criteria

I have been on bicalutamide for at least 30 days around the start of my GnRH agonist treatment.

I had hormone therapy for less than 3 months and stopped it over 3 months ago, with my testosterone levels now above 50ng/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant ADT

Participants receive neoadjuvant androgen deprivation therapy (ADT) for 3 months

3 months

SAbR Treatment

Participants receive Stereotactic Ablative Radiotherapy (SAbR) with varying schedules (every 2 weeks, every 3 weeks, every other day, or weekly) and undergo PSMA PET imaging to adapt treatment

Varies by cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of target intra-prostatic lesion(s)

3 months

What Are the Treatments Tested in This Trial?

Interventions

• 68-Ga PSMA11

Trial Overview

The trial is testing how well PET scans using a tracer called PSMA-11 can guide dose adjustments in SabR treatments for high-risk prostate cancer. It aims to find the best timing for imaging and treatment intervals to maximize response.

How Is the Trial Designed?

Group I: SAbR Every other day Experimental Treatment 1 Intervention

SAbR given 2-3/week, at least every other day in spacing with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.

Group II: PULSAR every week Experimental Treatment 1 Intervention

SAbR given 1/week, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.

Group III: PULSAR every 3 weeks Experimental Treatment 1 Intervention

SAbR given every 3 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.

Group IV: PULSAR every 2 weeks Experimental Treatment 1 Intervention

SAbR given every 2 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Telix Pharmaceuticals (Innovations) Pty Limited

Industry Sponsor

Trials

23

Recruited

2,400+

Once Upon a Time Foundation

Collaborator

Trials

4

Recruited

330+

Telix International Pty Ltd

Industry Sponsor

Trials

19

Recruited

1,300+

Published Research Related to This Trial

In a phase 2 trial involving 253 men with prostate cancer, PSMA-PET/CT significantly intensified radiation therapy (RT) in over half of the patients, indicating its potential to enhance treatment effectiveness.

New lesions were detected in a substantial percentage of patients, particularly in those with oligometastatic (45.5%) and salvage post-prostatectomy (51.6%) conditions, while the treatment was associated with minimal severe side effects (2.5% experienced grade 3+ events).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Petit, C., Delouya, G., Taussky, D., et al.[2023]

The preparation of [(68)Ga]PSMA-11 for PET-CT imaging in prostate cancer patients resulted in consistently high radiochemical yields of 93.19%±3.76%, with over 200 batches produced and no batch failures reported.

The radiopharmaceutical demonstrated high radiochemical purity (>99%) and was well-tolerated by over 300 patients, with no adverse reactions observed, indicating its safety and efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. Nanabala, R., Anees, MK., Sasikumar, A., et al.[2021]

In a study of 188 patients with rising PSA levels after prostate cancer treatment, 68Ga-PSMA PET/CT demonstrated a high detection rate of 87.8% for tumor relapse, identifying local recurrences and metastases effectively.

The diagnostic accuracy of 68Ga-PSMA PET/CT was exceptional, with sensitivity and specificity rates of 98.8% and 100%, respectively, making it a highly reliable tool for monitoring prostate cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. Hamed, MAG., Basha, MAA., Ahmed, H., et al.[2021]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

68Ga-PSMA-11 PET imaging shows significantly higher sensitivity and specificity for diagnosing prostate cancer compared to conventional imaging methods, making it a valuable tool for initial staging and detecting recurrence.

In cases of biochemical recurrence, 68Ga-PSMA-11 PET/CT has higher detection rates than choline PET/CT, particularly in patients with low PSA levels, and it has led to changes in treatment plans for over 25% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Significance of PSMA imaging in prostate cancer]. Gasch, C., Düwel, C., Kopka, K., et al.[2022]

The effective dose of [68Ga]PSMA-11 for imaging prostate cancer is 0.022 mSv/MBq, indicating a relatively low radiation exposure for patients.

In a study of six low-risk prostate cancer patients, the kidneys received the highest organ dose at approximately 40 mGy after a typical injection, while the eye lenses received a very low dose of 0.0051 mGy/MBq, suggesting a favorable safety profile for this imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. Sandgren, K., Johansson, L., Axelsson, J., et al.[2020]

99mTechnetium labeled PSMA SPECT-CT imaging is a cost-effective and simpler alternative to Gallium-68 PSMA PET-CT for diagnosing prostate cancer, including detecting primary tumors and metastases.

The study presents a case showing the use of 99mTc-PSMA imaging before therapy and 177Lu-PSMA imaging after therapy, highlighting the potential for effective monitoring of treatment response in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. Sheikh, N., Younis, MN., Mumtaz, M., et al.[2022]

In a study of 116 patients with intermediate to high-risk prostate cancer, 68Ga-PSMA-11 PET imaging detected primary tumors in 97% of cases and identified nodal and bone metastases in 24% and 12% of patients, respectively.

The use of 68Ga-PSMA-11 PET provided new staging information that could potentially change treatment plans for 27% of patients, indicating its significant impact on personalized patient management in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 68Ga-PSMA-11 PET staging on clinical decision-making in patients with intermediate or high-risk prostate cancer. Ferraro, DA., Garcia Schüler, HI., Muehlematter, UJ., et al.[2021]

[68Ga]Ga-PSMA-11 is a key radiopharmaceutical used for imaging prostate-specific membrane antigen (PSMA), which is crucial for managing recurrent prostate cancer.

The paper provides a comprehensive overview of the preclinical development and clinical applications of [68Ga]Ga-PSMA-11, comparing its effectiveness with other imaging methods to guide clinicians in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Bois, F., Noirot, C., Dietemann, S., et al.[2020]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

In a study of 19 patients with prostate cancer recurrences, 68Ga-PSMA-PET/CT-directed stereotactic body radiotherapy (SBRT) showed an 80.8% one-year PSA control rate, indicating its efficacy in managing oligometastases after surgery.

The treatment had a favorable safety profile, with no severe acute toxicity (G3+) reported, and only one case of temporary late G3-proctitis, suggesting that this approach is both effective and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-PET/CT-directed IGRT/SBRT for oligometastases of recurrent prostate cancer after initial surgery. Marzec, J., Becker, J., Paulsen, F., et al.[2021]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

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Baseline 68 Ga-PSMA-11 PET/CT whole-body tumor SUV mean was the best predictor of 177 Lu-PSMA-617 efficacy in participants in the VISION trial.

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Clinical Efficacy | Illuccix® (kit for the preparation of ...

View the established clinical efficacy for Illuccix® across prostate cancer stages demonstrated in pivotal trials with ⁶⁸Ga-PSMA-11.

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Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05847348

Study Details | NCT05847348 | 68Ga-PSMA-11 Efficacy in ...

This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new ...

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68 Ga-PSMA-11 PET resulted in a major change in management in 53% of patients with biochemical recurrence.

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pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ...

On 1 December 2020, almost 10 years after its discovery, [68Ga]Ga-PSMA-11 was approved by the Food and Drug Administration (FDA) [1] as the first 68Ga-labeled ...

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Safety, Dosimetry, and Feasibility of [68Ga]Ga-PSMA-R2 ...

68 Ga-PSMA-R2 was well tolerated, with no drug-related treatment-emergent adverse events. Safety and preliminary imaging performance data support further ...

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212642Orig1s000 - accessdata.fda.gov

Prostate cancer is most likely to spread initially to the pelvic lymph nodes, including the obturator, internal iliac, and external iliac. 22.