PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

NCT04642027 | Recruiting Phase 3

• 1 other identifier: RT2020-01
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 13

Brief Summary

After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years. The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT. The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy. The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA \< 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or three consecutive rises will be included. All eligible patients will be randomized to one of the following two treatment arms: Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks. Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks. The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.

Conditions

Prostate Cancer; Cancer Recurrence

Keywords

PSMA-PET/CT; Salvage; Hypofractionation; Radiotherapy; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 5-year progression-free survival

  Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first

  5 years

Secondary Outcomes (12)

• Acute grade ≥ 2 gastrointestinal toxicity

  Up to 3 months after completion of the RT

• Acute grade ≥ 2 genitourinary toxicities

  Up to 3 months after completion of the RT

• Late grade ≥ 2 gastrointestinal toxicity

  Up to 5 years after completion of the RT

• Late grade ≥ 2 genitourinary toxicity

  Up to 5 years after completion of the RT

• Quality of life after radiation

  Up to 5 years after completion of the RT

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Conventional sEBRT

Radiation: Conventional sEBRT

Hypofractionation

EXPERIMENTAL

Hypofractionated sEBRT

Radiation: Hypofractionated sEBRT

Interventions

Conventional sEBRT RADIATION

A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks

Also known as: Conventional salvage external beam radiation therapy

Conventional

Hypofractionated sEBRT RADIATION

A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks

Also known as: Hypofractionated salvage external beam radiation therapy

Hypofractionation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate adenocarcinoma treated with radical prostatectomy;
• Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
• No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
• PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
• Written (signed and dated) informed consent prior to registration.

You may not qualify if:

• Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
• Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
• Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
• Double-sided metallic hip prosthesis;
• Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator

Study Sites (13)

Radiotherapiegroep

Arnhem, Gelderland, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

RECRUITING

Maastro Clinic

Maastricht, Limburg, Netherlands

RECRUITING

Catharina-Hospital

Eindhoven, North Brabant, Netherlands

RECRUITING

Verbeeten Institute

Tilburg, North Brabant, Netherlands

RECRUITING

Amsterdam UMC (Location VUmc)

Amsterdam, North Holland, Netherlands

NOT YET RECRUITING

Radiotherapiegroep

Deventer, Overijssel, Netherlands

RECRUITING

Radiotherapy Institute Friesland

Leeuwarden, Provincie Friesland, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, South Holland, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

NOT YET RECRUITING

Haga Hospital

The Hague, South Holland, Netherlands

NOT YET RECRUITING

Zuidwest Radiotherapeutisch Instituut (ZRTI)

Flushing, Netherlands

RECRUITING

UMCG

Groningen, 9713GZ, Netherlands

RECRUITING

Related Publications (1)

• Staal FHE, Janssen J, Brouwer CL, Langendijk JA, Ng Wei Siang K, Schuit E, de Jong IJ, Verzijlbergen JF, Smeenk RJ, Aluwini S. Phase III randomised controlled trial on PSMA PET/CT guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer (PERYTON-trial): study protocol. BMC Cancer. 2022 Apr 15;22(1):416. doi: 10.1186/s12885-022-09493-5.

  PMID: 35428210 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• S. Aluwini, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

F. Staal, MD

CONTACT

0031655257985; f.h.e.staal@umcg.nl

P. Veldhuijzen van Zanten

CONTACT

0031503614659; peryton@rt.umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 randomised arms

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: November 24, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (13)