PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Essen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2025-07-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Deutsche Krebshilfe

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess difference in efficacy between curative-intent RT based on PSMA PET vs based on standard-of care imaging, in patients with primary prostate cancer (intermediate- or high-risk) for whom curative-intent RT is appropriate given the imaging results.

Secondary objectives 1

1. To assess safety and the impact on management of curative-intent RT based on PSMA PET vs based on standard-of care imaging.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male
2. 18 years of age or older
3. Signed an informed consent form (ICF) indicating that the participant understands the purpose of, and the procedures required for the study and is willing to participate in the study: participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
4. Histopathology-confirmed adenocarcinoma of the prostate.
5. Intermediate- to high-risk disease (PSA>10ng/mL, cT-stage≥2b, Gleason score≥7 or Decipher Score ≥0.45)
6. Willingness to undergo radiotherapy.
7. Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (arm 2)
8. Eastern Cooperative Oncology Group Performance Status Grade 0 or 1.
9. The participant must wear a condom when engaging in any sexual activity that allows the passage of ejaculate to another person while on study intervention, and for 24 hours following the dose of study intervention. Participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
10. The participant must agree not to donate sperm for the purpose of reproduction until 24 hours following the dose of study intervention

Exclusion criteria 16

1. Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization.
2. Active malignancies (i.e., Progressing or requiring treatment change in the last 24 months) other than disease being treated under study. Allowed exceptions [...]
3. Contraindications to radiotherapy (including active inflammatory bowel disease)
4. Concurrent or prior surgery or systemic therapy for prostate cancer
5. Any kind of radiopharmaceutical within a period corresponding to 8 half-lives of the respective radionuclide
6. Any other investigational medicinal product within 2 days or within 5 times the elimination half-life of the respective investigational product prior receiving study intervention
7. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant
8. Prior PSMA PET
9. Prior pelvic RT
10. Previous treatment with ADT for prostate cancer
11. Prior treatment with a CYP17 inhibitor (e.g., oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
12. Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
13. Any of the following within 6 months prior to the trial intervention: severe or unstable angina, myocardial infarction, pulmonary embolism, stroke, clinically significant ventricular arrhythmias or NYHA Class II to VI heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
14. Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization
15. Prior chemotherapy for prostate cancer
16. Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 of the SmPC of 68Ga-PSMA-11 or to any of the components of the labelled radiopharmaceutical

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS), defined as time from initiation of RT to - biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] - appearance of metastases or loco-regional recurrence as defined below - death from any cause whichever occurs first

Secondary endpoints 6

1. Change in initial treatment intent
2. Metastasis-free survival (MFS), defined as time from initiation of RT to occurrence of new metastases defined as - PET or radiographic bone or soft tissue distant metastases by blinded independent central review* - pathologic finding of distant metastases - death from any cause whichever occurs first
3. Loco-regional control (pelvis) Occurrence of loco-regional progression defined as (whichever occurs first): - PET or radiographic pelvic non-bone PCa lesions by blinded independent central review* - Pathologic finding of pelvic non-bone PCa lesions
4. Overall survival (OS), defined as time from initiation of RT to death from any cause.
5. Post-salvage bPFS - In patients without salvage therapy: Time from initiation of RT until progression as defined above (primary endpoint) - In patients with salvage therapy: Time from initiation of RT until progression post-salvage therapy as defined above (primary endpoint) *Following the joint EAU ESUR ESTRO SIOG 2018 guideline, Section 6.3.4.4
6. Safety endpoints: Adverse events of CTC grade ≥3 and serious adverse events (SAE) according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, v5.0, 2017).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Essen AöR

Sponsor organisation

Universitaetsklinikum Essen AöR

Address

Hufelandstrasse 55, Holsterhausen Holsterhausen

City

Essen

Postcode

45147

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Essen AöR

Contact name

Wolfgang Fendler

Public contact point

Organisation

Universitaetsklinikum Essen AöR

Contact name

Studienzentrum GmbH

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications