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Active, Not Recruiting

NCT Number: NCT03525288

PSMA-PET Guided Radiotherapy

PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CSSSL - Cité de la Santé Laval, Laval, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
  • Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
  • ECOG 0-1
  • Charlson Cormobidity Index ≤ 4
  • High-risk of distant metastases as defined by any of:
  • Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.
  • Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
  • Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
  • Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Exclusion criteria

  • Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
  • Prior or planned PET scan.

Treatment and study plan

PSMA -PET/CT simulation

Radiation
  • PET/CT simulation.
  • If no additional lesions detected: RT as planned per standard care.
  • If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT.
  • If PSMA-PET/CT imaging consistent with widely metastatic disease (>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.

Standard-care simulation

Radiation

No PSMA-PET/CT as part of RT treatment planning.

Primary outcomes

  1. Failure-free survival

    Time frame: 5 years

    Time to failure event

Secondary outcomes

  1. Acute and delayed toxicities

    Time frame: 5 years

    Rate of Attributable Gr2+ toxicities (CTCAE v4.0)

  2. Rate of failure

    Time frame: 5 years

    Event rates

  3. Survival

    Time frame: 5 years

    Event rates

  4. Health-related quality of life

    Time frame: 5 years

    Qol measures

  5. Detection yield of PSMA PET imaging

    Time frame: 2 years

    Rate of new lesions identified on imaging

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study title

PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer

Acronym: PSMA-PETgRT

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
May 15, 2018
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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