PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

Phase 3RecruitingNCT04642027

University Medical Center Groningen538 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

538

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * PSA at inclusion \< 1.0 ng/mL; * WHO performance status 0-2 at inclusion; * Age at inclusion between 18 and 80 years; * Written (signed and dated) informed consent prior to registration. Exclusion Criteria: * 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.

Locations (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

...and 3 more locations

Outcomes

Primary Outcomes

5-year progression-free survival

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

Time frame: 5 years

Secondary Outcomes

Acute grade ≥ 2 gastrointestinal toxicity

As assessed using physician-reported score: Common Terminology Criteria for adverse events version 5.0 (CTCAE-5) toxicity score with a scale of 1 - 4.

Time frame: Up to 3 months after completion of the RT

Acute grade ≥ 2 genitourinary toxicities

As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).

Time frame: Up to 3 months after completion of the RT

Late grade ≥ 2 gastrointestinal toxicity

As assessed using physician-reported score (CTCAE 5.0 toxicity score).

Time frame: Up to 5 years after completion of the RT

Late grade ≥ 2 genitourinary toxicity

Using physician-reported score (CTCAE 5.0 toxicity score).

Time frame: Up to 5 years after completion of the RT

Quality of life after radiation

As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30

Time frame: Up to 5 years after completion of the RT

Metastasis-free survival

Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan).

Time frame: 5 years

Prostate cancer-specific mortality

Prostate cancer-specific mortality.

Time frame: 5 years

Overall survival

Time frame: 5 years

Acute grade ≥ 2 gastrointestinal toxicity

Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

Time frame: Up to 3 months after completion of the RT

Acute grade ≥ 2 genitourinary toxicities

Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

Time frame: Up to 3 months after completion of the RT

Late grade ≥ 2 genitourinary toxicity

Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).

Time frame: Up to 5 years after completion of the RT

Quality of life after radiation

As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25).

Time frame: Up to 5 years after completion of the RT

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

Overview

Conditions

Interventions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts